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

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