Quality Systems Manager

Job Summary

The Quality Systems Manager is responsible for administering improvements within the Quality System to address
issues and trends effectively and in compliance with regulatory requirements and standards. The Quality Systems
Manager will lead a team of professionals to manage various aspects of the Quality System and to achieve overall
business unit metrics, provide Quality representation and support related to Quality Systems and production
changes, customer management, and equipment qualification and support.

Duties and Responsibilities

• Manage Document Control, support BHR Review, and other functions to help ensure departmental coverage
• Review document changes to ensure compliance with the Quality System; develop quality systems and
procedures as needed
• Manage Internal Audit, CAPA/Complaint, and Supplier Quality programs
• Analyze Internal Quality, CAPA/Complaint, Supplier Quality defect data to define and resolve root causes
• Prepare reports by collecting, analyzing, and summarizing data
• Ensure compliance to regulatory and customer requirements
• Oversee training program in production practices and quality assessment of goods
• Monitor, analyze and report effectiveness of quality system
• Support the implementation of continuous improvement initiatives for productive processes; participate in crossfunctional team environments to address CAPA and continuous improvement activities
• Ensure adequate corrective and preventative actions are identified and implemented
• Comply with all work rules including those pertaining to safety, health, and SiO2 QMS
• Lead a team of support personnel
• Excellent organizational skills to ensure a clean and orderly work environment
• Proficient use in Microsoft Office Suite
• Other duties as assigned

Required Skills/Abilities

• Formal training in Quality-related fields and ASQ or similar certification as Quality Technician or Quality Auditor
preferred
• Knowledgeable of FDA Quality System Regulations (21CFR Part 820) and ISO 13485 as applicable to
manufacturing environments that produce components or devices for the medical industry
• Demonstrated ability to implement and administer quality programs and interpret CAPA/Complaint data to drive
continuous improvement
• Proficient use in Microsoft Office Suite; knowledge/experience in Microsoft Visio and Project a plus
• Strong ability to change approach/method to maximize efficiency
• Strong attention to detail with good documentation practices
• Ability to follow detailed instructions quickly and effectively
• Through knowledge of Lean Six Sigma manufacturing
• Ability to adapt to frequent changes, delays, or unexpected events in the work environment
• Ability to manage competing demands
• Ability to learn new computer software and processes rapidly
• Ability to recognize and comprehend important information quickly
• Strong reasoning and judgment skills to ensure timely, sound decisions even under conditions of risk,
uncertainty, and incomplete information
• Ability to act with professionalism, integrity, and superior confidentiality
• Strong communication/interpersonal skills as well as time management skills
• Ability to include appropriate people in decision-making process
• Ability to work independently as well as with a team
• Strong team building skills; promoting a positive team spirit, exhibiting objectivity and openness to views and
opinions of coworkers
• Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to
continuously build knowledge and skills

Education and Experience

• Typically, Technical degree plus two (2) years’ experience in manufacturing, management, and/or an ISO quality
systems role
• High School diploma or equivalent requires four (4) years’ experience in manufacturing, management, and/or an
ISO quality systems role

Physical Requirements

• Prolonged periods of sitting/standing
• Standard forty (40) hour work week with additional time as needed to meet company objectives
• Ability to access and navigate each department at the organization’s buildings to include walking to and from
offices/building sites, and climbing/descending stairs
• Ability to hear and react to audible alarms from distances up to 150 feet
• May involve repetitive motion

Mechanical Engineer

Job Summary

Provide technical engineering services for new and commercialized products and processes. In this highly technical
position, the individual will be a key contributor to product and process development and sustaining engineering; as
well as qualifying and transferring products, equipment and processes from R&D into Manufacturing. The individual
will work closely with R&D, Manufacturing, Quality, Operations, and Applications Engineering Program
Management; as well as with outside consultants, contract engineering companies, suppliers, universities, codevelopers and customers.

Education, Experience, and Skills

• Bachelors degree in an engineering or science discipline or 5+ years of company-specific experience required.
• Minimum of 2 years experience in engineering preferred.
• Advanced technical degree is a plus.
• Project management experience is a plus.
• Medical products or pharmaceutical company experience producing FDA and ISO regulated products under
21CFR 820/QSRs, and ISO-13485 regulations
• Prefilled syringe product and/or components experience is a plus
• Excellent interpersonal, verbal communication, and technical writing skills (writing verification and validation
protocols and reports, work instructions; presenting technical results, etc)
• Collaborative cross-functional approach to parallel product and process development is essential
• Excellent SolidWorks solid model CAD skills is essential
• ANSYS computer aided simulation software experience is a plus
• Heat transfer, fluid dynamics, mechanics, dynamics, strength of materials, thermodynamics, and material
science
• SolidWorks EPDM administration experience is a plus
• Process scale up
• Design controls
• Experienced and trained in World Class Manufacturing and Product Development Best Practices:
• Six Sigma disciplines and techniques
• Design of Experiments
• Applied statistics
• Lean manufacturing disciplines and techniques
• TQM
• Technology experience:
        • Machine design
        • Automation design
        • Vision systems
        • Machining processes
        • System integration experience is a plus
        • Injection molding, stretch blow molding, elastomer molding is a plus
        • Spraying and other coating systems experience is a plus
        • Plasma enhanced chemical vapor deposition systems experience is a plus

Equipment, Machines, and Tools Used

• Personal Computer, Microsoft Office suite of software, Solid Works CAD software, inspection and measuring
equipment, and analytical test equipment.

Physical Requirements

• Daily standing, computer usage, sitting, lifting, pushing, and pulling.

Molding Technician

Job Summary

The Molding Technician position will support the molding activities at SiO2 in Auburn, AL, and will report to the Process Manager. This individual’s primary responsibility will be to oversee the technical aspects of the molding cleanroom(s) during their shift, and to ensure quality product is being produced.

Duties and Responsibilities

• Direct and monitor the execution of the production schedule
• Complete daily shift report
• Monitor machine operation for compliance with all ISO, health, safety, quality and efficiency standards
• Collaborate with Quality, Engineering, Tooling and Maintenance to identify and resolve equipment and quality problems within the molding cells
• Performing mold and material changes based on the dictated schedule
• Perform process troubleshooting
• Verifying paperwork and completion of inspections at start up and in process inspections are being completed
• Monitoring and preparing support equipment
• Follow established procedures in order to maintain a safe, clean and organized work area on a daily basis
• Assisting on break coverage
• Ability to learn other processes & equipment, such as injection-stretch blow-molding, robotics, etc.

Experience/Skills

• Experience with Injection Molding with a focus on processing.
• RJG Master Molder certification, AIM or similar a plus.
• Basic Injection Molding Tooling Background required.
• Good mechanical & troubleshooting skills.
• Excellent communication skills.
• Must be self-driven

Physical Requirements

• Prolonged periods of sitting/standing/walking
• Standard forty (40) hour work week with additional time as needed to meet company objectives
• Minimal to no travel required (10% or less annually)
• Ability to access and navigate each department at the organization’s buildings to include walking to and from offices/building sites, and climbing/descending stairs
• Ability to see with or without corrective lenses and distinguish color differences and depth perception for product and safety issues
• Ability to hear and react to audible alarms from distances up to 150 feet
• Ability to lift/carry up to fifty (50) pounds

Other Details:

Shifts: 2-2-3 schedule
Day Shift: 5:50 am – 6:00 pm
Night Shift: 5:50 pm – 6:00 am
Openings for day and night shift. Salary ranges from $25-$35/hr.

Maintenance Technician

Job Summary

The Maintenance Technician will be responsible for conducting general maintenance and repairs on facility equipment and property structures. The Maintenance Technician will also ensure that heating and plumbing systems perform at optimum functionality. The goal of this position is to maintain the facilities and common areas in the best possible condition.

Duties and Responsibilities

• Ability to respond quickly in the event of an emergency, notify appropriate personnel, and follow safety protocol
• Ability to survey buildings to ensure they are consistent with health and safety regulations
• Ability to undertake activities of pest control (spraying insecticide)
• Maintain neat, clean, and orderly facilities
• Maintain heating and plumbing systems to ensure functionality
• Inspect alarm systems (carbon dioxide, fire protection) and quickly schedule repairs as needed
• Strong time management and organizational skills to effectively meet assigned goals
• Other duties as assigned

Required Skills/Abilities

• Basic understanding of electrical systems
• Strong understanding of general maintenance processes and methods
• Experience in operating a variety of equipment
• Excellent organizational, time management, and attention to detail skills
• Working knowledge of tools, common appliances, and devices
• Ability to act with professionalism, integrity, and superior confidentiality
• Excellent manual dexterity and problem-solving skills
• Ability to prioritize tasks and delegate when appropriate
• Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to continuously build knowledge and skills

Education and Experience

• High school diploma or GED
• Prior Maintenance Technician experience

Physical Requirements

• Prolonged periods of sitting/standing/walking
• Standard forty (40) hour work week with additional time as needed to meet company objectives
• Ability to access and navigate each department at the organization’s buildings to include walking to and from offices/building sites, and climbing/descending stairs
• Ability to hear and react to audible alarms from distances up to 150 feet
• Ability to lift/carry up to fifty (50) pounds

Other Details:

Shifts: 2-2-3 schedule
Day Shift: 5:50 am – 6:00 pm
Night Shift: 5:50 pm – 6:00 am
Openings for day and night shift. Salary ranges from $25-$35/hr.

Automation Technician I

Job Summary

Integrate and support SiO2 automation systems. Uses basic technical skills to operate, maintain, troubleshoot,
repair, and set up plant production equipment. This is a progressive position. With appropriate training
and experience the Automation Technician I will be on the path to Automation Technician II.

Duties and Responsibilities

• Operate production equipment in assigned area.
• Monitor requirements for safety, quality, and production.
• Drive continuous improvement by assessing plant processes and identify opportunity for process and automation opportunities to improve quality and productivity.
• Support maintenance team with advanced mechanical and electrical troubleshooting opportunities and identifying opportunities for value added improvements.
• Collaborate with Operations and Maintenance teams to ensure equipment is properly operated and maintained.
• Maintain process sensors maintenance; complete sensor verification, analyze issues, and recommend solutions.
• Coordinate changeovers and ensure accuracy.
• Perform basic equipment repairs within scope of work.
• Execute preventative and general maintenance as needed.
• Complete training to enhance and advance skills.
• Other duties as assigned.Required Skills/Abilities
• Intermediate troubleshooting skills using mechanical, electrical, and pneumatic knowledge.
• Ability to troubleshoot equipment problems and perform complex system tests.
• Creative thinking skills
• Detail-oriented personality
• Ability to define problems, collect data, when necessary, establish facts, and draw valid conclusions.
• Ability to communicate well and build strong relationships with others.
• Thrive under pressure.
• Prefer experience in:
        • PLC, Vision Systems, Equipment Validation and Process Validation.
        • Equipment Documentation and change assessments.
        • GMP regulations.
        • Troubleshooting
• Basic computer skills
• Good teamwork, interpersonal, and communication skills
• Fluent in English

Education and Experience

• Mechatronics, Industrial Maintenance, or similar degree or completion of SiO2 Master Class Automation
Technician I Training Program.
• Prefer minimum of 5-7 years of manufacturing experience

Other Details:

Shifts: 2-2-3 schedule
Day Shift: 5:50 am – 6:00 pm
Night Shift: 5:50 pm – 6:00 am
Openings for day and night shift. Salary ranges from $30-$40/hr.

Network Engineer

Job Summary

The Network Engineer will implement equipment installation plans, maintain components of the network, and troubleshoot issues. He/she will be responsible for monitoring the network firewall, assessing the functionality of network routers, ensuring Internet security software is regularly updated, developing/implementing company email policies, and maintaining the company phone system.

Duties and Responsibilities

  • Respond to network connectivity issues; resolve any wireless communication issues
  • Sustain necessary data throughput rate by monitoring network activity and maintaining equipment
  • Maintain the company phone system
  • Update the network maintenance manual; submit a summary of changes to the manual weekly
  • Collaborate with third party support/vendors to ensure the network stays operational
  • Ability to comply with local, state, and federal laws
  • Strong organizational and attention to detail skills
  • Effective time management skills
  • Excellent written and oral communication skills
  • Knowledge of MS Word, Excel, and Outlook
  • Willingness to work as a team member, recognizing and encouraging other team members
  • Other duties as assigned

Required Skills/Abilities

  • Ability to work under pressure
  • Working knowledge of technology equipment
  • Strong verbal and written communication skills
  • Ability to adapt to frequent changes, delays, or unexpected events in the work environment. Ability to problem solve
  • Strong reasoning and judgment skills
  • Ability to act with professionalism, integrity, and superior confidentiality
  • Ability to prioritize tasks and delegate when appropriate
  • Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to continuously build knowledge and skills

Education and Experience

  • High school diploma or GED
  • Bachelor’s degree in Information Technology or related field preferred
  • Minimum five (5) years’ experience in managing computer networks in lieu of bachelor’s degree
  • Cisco Certified Internetwork Expert (CCIE) certificate preferred
  • CompTIA networking certifications preferred

Experience needed: 

  • VMWare
  • Windows server
  • SQL
  • Active Directory
  • Windows firewall

Other details: 

  • Position is based in Auburn Alabama
  • Relocation assistance will be provided
  • Salary depending on experience

Quality Inspector I

Job Summary

The Quality Inspector I is responsible for performing quality assurance inspections that includes all visual, and any functional testing required as a part of the component release documentation related to the manufacturing process of products.  The QA Inspector I will inspect materials, parts, and products at various stages of production against specification, then record observations and may make recommendations for improving processes.   The QA Inspector I also inspects the production processes and documentation as it relates to the SiO2 Materials Science manufacturing operations to be in compliance with SiO2 Materials Science policies, SOP, cGMP, ISO13485, ISO 15378, and ISO 9001 standards, as well as the SiO2 Materials Science Quality Manual.  The QA Inspector I will also perform and document all Batch Release Inspections for the operations that can include SPC and CoA documentation.

Duties and Responsibilities

  • Ability to learn, teach and enforce SiO2 Medical Products paperwork, policies, SOP, ISO 13485, ISO 15378, ISO 9001, safety, SPC, and the operation of testing machines
  • Comfortable with working under immediate supervision
  • Ability to maintain quality standards by approving incoming materials, in-process production, and finished products
  • Ability to be able to properly collect and record data as well as discuss quality results
  • Must be able to read and understand drawings and specifications
  • Ability to perform a variety of tasks both on the production floor, in the lab, warehouse and on a computer
  • Ability to provide support to research and development, manufacturing, and engineering
  • Knowledge of Lean Six Sigma manufacturing practices
  • Knowledge of computers, specifications, inspection, measuring and test equipment
  • Excellent written and oral communication skills
  • Willingness to work as a team member
  • Other duties as assigned

Required Skills/Abilities

  • Strong analytical and problem-solving skills
  • Knowledge of/prior experience with inspection, measuring, and test equipment
  • Ability to adapt to frequent changes, delays, or unexpected events in the work environment
  • Excellent organizational and attention to detail skills
  • Strong reasoning and judgment skills
  • Ability to act with professionalism, integrity, and superior confidentiality
  • Ability to prioritize tasks and delegate when appropriate
  • Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to continuously build knowledge and skills

Education and Experience

  • High school diploma or GED
  • Zero to two manufacturing experience

Quality Team Lead

Job Summary

The Quality Team Lead is responsible for performing quality assurance inspections that includes all visual, and any functional testing required as a part of the component release documentation related to the manufacturing process of products.  The Quality Team Lead will also inspect materials, parts, and products at various stages of production against specification, then record observations and make recommendations for improving processes.   The Quality Team Lead also inspects the production processes and documentation as it relates to the SiO2 Materials Science manufacturing operations to be in compliance with SiO2 Materials Science policies, SOP, cGMP, ISO13485, ISO 15378, and ISO 9001 standards, as well as the SiO2 Materials Science Quality Manual.  The Quality Team Lead will perform and document all Batch Release Inspections for the operations that can include SPC and COA documentation.

Duties and Responsibilities

  • Ability to learn, teach and enforce SiO2 Materials Science paperwork, policies, SOP, ISO 13485, ISO 15378, ISO 9001, safety, SPC, and the operation of testing machines
  • Ability to rely on experience and judgment to plan and accomplish goals
  • Ability to work under minimal supervision
  • Ability to maintain quality standards by approving incoming materials, in‐process production, and finished products
  • Ability to be able to properly collect and record data as well as discuss quality results
  • Must be able to read and understand drawings and specifications
  • Ability to perform a variety of tasks both on the production floor, in the lab, warehouse and on a computer
  • Ability to provide support to research and development, manufacturing, and engineering  Knowledge of Lean Six Sigma manufacturing practices
  • Knowledge of computers, specifications, BHR preparations, inspection, measuring, test equipment, and relabeling product to represent the final disposition
  • Excellent written and oral communication skills
  • Willingness to work as a team member
  • Other duties as assigned

Required Skills/Abilities

  • Strong analytical and problem‐solving skills
  • Prior experience with inspection, measuring, and test equipment
  • Ability to adapt to frequent changes, delays, or unexpected events in the work environment
  • Excellent organizational and attention to detail skills
  • Strong reasoning and judgment skills
  • Ability to act with professionalism, integrity, and superior confidentiality
  • Ability to prioritize tasks and delegate when appropriate
  • Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to continuously build knowledge and skills

Education and Experience

  • High school diploma or equivalent and four (4) to six (6) years’ manufacturing experience
  • Prior experience with Minitab SPC charts, and SAP Business One Software

Quality Supervisor

Job Summary

The Quality Supervisor will be responsible for overseeing and monitoring the inspection and testing of materials, parts, and products to ensure established quality standards are met. The Quality Supervisor will establish inspection protocols, define sampling procedures, and determine equipment/mechanisms to be used in the testing process.

Duties and Responsibilities

  • Ability to accomplish department objectives by supervising staff, organizing, and monitoring work processes Maintain staff by training/developing
  • Knowledge of Lean Six Sigma manufacturing practices
  • Ability to coach/counsel staff
  • Ability to implement and enforce company policies and procedures
  • Strong customer service minded ensuring quality products
  • Strong time management and organizational skills to effectively meet assigned deadlines
  • Excellent written and oral communication skills
  • Ability to maintain safe, healthy, clean work environments
  • Ability to maintain schedules and work assignments
  • Knowledge of MS Word and Excel
  • Basic knowledge of SAP/MES systems
  • Other duties as assigned

Required Skills/Abilities

  • Strong analytical and problem-solving skills
  • Ability to adapt to frequent changes, delays, or unexpected events in the work environment Strong team building abilities
  • Excellent organizational, time management, and attention to detail skills
  • Strong reasoning and judgment skills
  • Ability to act with professionalism, integrity, and superior confidentiality
  • Ability to prioritize tasks and delegate when appropriate
  • Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to continuously build knowledge and skills

Education and Experience

  • High school diploma or equivalent required; Bachelor’s degree preferred
  • Minimum three (3) to five (5) years’ prior quality/supervisory experience
  • Ability to convey conclusions and recommendations concisely in properly formatted, well-written reports