Quality Engineer II

Job Summary

The Quality Engineer II will provide hands on QE support for Engineering and Production.  He/she will provide audit support for third party audits and customer audits as well as perform internal audits and supplier audits.  He/she will also interact with customers and suppliers in support of engineering projects.

Duties and Responsibilities

  • Develop quality systems and procedures as required to meet statutory or regulatory requirements
  • Review document and procedure changes for quality requirements and compliance with the quality system  Provide quality support for the disposition of material
  • Support the implementation of continuous improvement initiatives for operations
  • Ability to comply with company policies/procedures pertaining to safety, health, quality, QSR’s, and the Quality Management System
  • Knowledge of Lean Six Sigma manufacturing practices
  • Knowledge of MS Word and Excel
  • Provide resource allocation of quality support
  • Provide first Quality contact for customer complaint handling
  • Provide sponsorship and act as facilitator for SPC, FMEA, DOE and process validation systems
  • Facilitate development and implementation of IQ, OQ and PQ to ensure compliance with the Quality System
  • Provide QE support, analysis, and recommendations for Product Development to successfully launch new products into active production in a timely and cost‐effective manner
  • Ability to follow established guidelines to daily maintain a safe, clean, and organized work area
  • Willingness to work as a team member
  • Other duties as assigned

Required Skills/Abilities

  • Must be familiar with and understand recognized regulations and standards such as (where applicable) o 21 CFR Part 820 (FDA QSR, cGMP) o ISO 13485 Medical Devices – Quality Management Systems o ISO 14971 Risk Management o ISO 9001 Quality Management Systems
  • Demonstrated leadership skills
  • Able to be technically comprehensive and knowledgeable including standard business ERP system principles, as well as technical aspects such as statistics, documentation, SPC, Geometric Tolerancing, and mechanical drawings and associated software packages
  • Familiar with Six Sigma and/or a history of lean manufacturing, Kaizen and 5S, etc.
  • Six‐Sigma certified or willing to obtain certification preferred
  • Must possess excellent verbal & written communication skills, as well as presentation, organizational and management skills
  • Prior experience with environmental controls, biocompatibility and associated control systems preferred
  • Knowledge of machining, metals and plastics processing and fabrication, and product assembly in the medical device industry
  • Ability to adapt to frequent changes, delays, or unexpected events in the work environment
  • Strong time management skills to meet assigned deadlines
  • Excellent organizational and attention to detail skills
  • Ability to interface with customers, problem solve and drive solutions to meet customer requirements
  • Strategic thinker – responsible for contributing to the development of the plan; ability to conceptualize coherent view of facility in the future (six months, one year, two years, five years)
  • Must possess excellent verbal, written, and presentation communication skills
  • Rational thinker – good business judgment and ethics
  • Strong communicator with internal and external customers (written and verbal) (one‐on‐one and group)
  • Entrepreneurial attitude and mindset combined with the appropriate process orientation, focus and willing to embrace change
  • Self‐motivated with a sense of urgency and accountability
  • Energetic and hardworking
  • High level of intellectual curiosity combined with strong problem solving and analytical skills
  • Innovative, practical, technically astute, and capable of healthy dialogue in the exchange of ideas in reaching conclusions
  • Ability to act with professionalism, integrity, and superior confidentiality
  • Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to continuously build knowledge and skills

Education and Experience

  • Typically, Bachelor’s degree in engineering, equivalent degree, or extensive work experience
  • Minimum eight (8) years’ equivalent work experience in lieu of education.
  • Minimum four (4) to twelve (12) years’ experience in manufacturing, preferably medical devices, pharmaceuticals, aerospace, food, automotive or other regulated industries, including at least three years leadership responsibilities with increasing responsibility in quality assurance or associated fields

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

Quality Inspector III

Job Summary

The Quality Inspector III is responsible for directing and coordinating activities related to nonconforming material, retains, and incoming inspection. The Quality Inspector III will conduct material review board (MRB) meetings along with identifying, 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 Inspector III 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 Inspector III 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 Inspector III will perform and document all disposition of Nonconforming Product and Batch Release Inspections for the operations that can include SPC and COA documentation.

Duties and Responsibilities

  • Overall coordination, tracking/status of all in-house MRB material
  • Interface with various departments to provide status of open MRB items and seek to closure on those items Process dispositioned material
  • Properly initiates material transfers and records transactions in SAP as needed to preserve traceability and inventory accuracy
  • Creates, updates, executes, and analyzes MRB reports
  • Ensure that all documents and material received in the warehouse meets requirements per Incoming Inspection Record (IIR)
  • 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 limited experience and judgment to plan and accomplish goals
  • Ability to work under limited 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

  • Adept verbal and written communication
  • 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 2-4 years manufacturing experience

Sterility Assurance Program Manager

Job Summary

The Sterility Assurance Program Manager is responsible for expertise in the area of sterility assurance for all sterilization processes.  This position collaborates with R&D, Production, and other areas to define process development and qualification activities for new products as it relates to sterilization of products.  In addition, manages all aspects of the sterility assurance program to include, but not limited to; component qualification, environmental controls, change control including facility qualification/ change assessment and product introduction/ change assessment, bioburden program, and all sterilization validation activities and routine release.  Oversees the microbiology laboratory and environmental monitoring staff.

Duties and Responsibilities

  • Manage quality aspects of routine sterilization and sterilization validation, to include assessment of changes (facility, process, product) that could potentially impact sterility assurance levels.
  • Manages environmental control program including monitoring and related failure investigations.
  • Manages product / component bioburden program and related investigations in support of sterilization validation.
  • Must be able to interact with internal and external customers in a professional manner both orally and in written communications.
  • Staff management – direct employees in a manner to ensure responsibilities are executed as required as dictated by the needs of the organization.
  • Regulatory compliance – ensures all activities are executed in full compliance with the most current and relevant standards (e.g. ISO 13485, ISO 14644, ISO 11137, FDA 21 CFR Part 820).
  • Staff selection, assessment, and development – ensures employees are proficient in areas of responsibility.
  • Responsible for housekeeping and safety awareness for areas of responsibility.
  • Participate in audits of sterilization and laboratory services.
  • Proficient use in Microsoft Office Suite
  • Other duties as assigned.

Required Skills/Abilities

  • 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.
  • Expertise in irradiation sterilization and associated international standard(s), ISO 11137.
  • Knowledgeable of EO sterilization validation and associated international standard(s), ISO 11135.
  • Knowledgeable in facility qualification as it related to controlled environments and cleanrooms, ISO 14644
  • Knowledgeable in standard microbiological testing relevant to medical device and/ or pharmaceutical industries, such as bioburden and sterility.
  • Strong problem-solving skills as it related to microbiological contamination control (environment, bioburden, sterility). Ability to drive investigation to closure.
  • Strong attention to detail with good documentation practices.
  • Ability to manage competing demands, set priorities to ensure compliance and meet company goals.
  • Strong reasoning and judgment skills to ensure timely, sound decisions even under conditions of risk, uncertainty, and incomplete information – ability to determine when to escalate a situation when required.
  • 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

  • Bachelor’s degree in biological science discipline plus five (5) years’ experience in management of controlled environments and terminal sterilization.

Microbiologist

Job Summary

The Microbiologist is responsible for expertise in the area of industrial microbiology as it relates to terminally sterilized products.  This position will lead efforts to develop, validate, and execute microbiological testing, in support of component qualification, environmental controls, change control including facility qualification/ change assessment and product introduction/ change assessment, bioburden program in support of the sterility assurance program.

Duties and Responsibilities

  • Manage quality aspects of routine microbiological testing.
  • Manages environmental control program including monitoring and related failure investigations.
  • Manages product / component bioburden program and related investigations in support of sterilization validation.
  • Lead failure investigations that are related to microbiological testing.
  • Must be able to interact with internal and external customers in a professional manner both orally and in written communications.
  • Regulatory compliance – ensures all activities are executed in full compliance with the most current and relevant standards (e.g. ISO 11737, ISO 14644, ISO 13485, and FDA 21 CFR Part 820).
  • Responsible for housekeeping and safety awareness for areas of responsibility.
  • Participate in audits of sterilization and laboratory services.
  • Proficient use in Microsoft Office Suite
  • Other duties as assigned.

Required Skills/Abilities

  • 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.
  • Experience in irradiation sterilization and associated international standard(s), ISO 11137.
  • Knowledgeable of EO sterilization validation and associated international standard(s), ISO 11135.
  • Knowledgeable in facility qualification as it related to controlled environments and cleanrooms, ISO 14644
  • Knowledgeable in standard microbiological testing relevant to medical device and/ or pharmaceutical industries, such as endotoxin, bioburden and sterility.
  • Strong problem-solving skills as it related to microbiological contamination control (environment, bioburden, sterility). Ability to drive investigation to closure.
  • Strong attention to detail with good documentation practices.
  • Ability to manage competing demands, set priorities to ensure compliance and meet company goals.
  • Strong reasoning and judgment skills to ensure timely, sound decisions even under conditions of risk, uncertainty, and incomplete information – ability to determine when to escalate a situation when required.
  • 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

  • Bachelor’s degree in biological science discipline plus three (3) years’ experience in an industrial microbiology laboratory.