Principal Quality Engineer

Imperative Care•Campbell, CA

9d•$173,000 - $192,000•Onsite

About The Position

The Principal Quality Engineer is the subject matter expert who establishes processes, protocols, methods, and techniques to ensure compliance with quality standards and regulatory requirements during the development, manufacture and distribution of our medical device products. This role will involve leading sterilization and biocompatibility activities and/or overseeing the work of more junior team members or contracted testing laboratories, depending on focus area. Develop and execute quality plans and provide strategic input throughout the product development lifecycle to ensure products comply with regulatory and internal quality systems requirements. Share data analytics related to quality metrics. Participate in product development by developing protocols and overseeing quality standards implementation in the design control system. Provides microbiological, sterilization and biocompatibility technical expertise, when applicable, during new product development activities, process modification studies and failure investigations regarding microbiological contamination control, impact to product and validated sterilization cycles. Serves as technical liaison with functional groups, contract laboratories and manufacturing sites. Oversee the Risk Management Report process and contribute to the development of Use Risk, Design Risk and Process Risk documentation. Collaborate cross-functionally on pilot production of new products and improvement projects. Establish and maintain quality assurance procedures and educate peers on their use. Manage relationships with suppliers and testing laboratories by developing quality agreements, assessing performance, troubleshooting failures and creating corrective action plans. Participate in supplier qualification activities, including on-site audits and evaluations. When a position’s focus is microbiology, sterilization and biocompatibility, lead all activities and projects related to laboratory selection, compliance audits, along with testing analyses and results interpretation. Develop and implement sterilization protocols and procedures according to regulations. Plan and execute validation studies of sterilization and assessments and requalification activities. Generate Biological Evaluation Plans (BEPs), analyse testing results and assess biocompatibility risks. Advise on biocompatibility tests to be performed. Keep accurate/detailed documentation of sterilization test results, methodologies and conclusions. Provide training and guidance on sterilizations requirements and best practices. Participate in the maintenance and compliance of quality systems, pre-production/post-production QA procedures, pre-clinical testing programs in coordination with other teams. Review and assess DCOs, complaints, CAPAs and NCMRs to identify new/revised risks. Conduct benefit-risk evaluation on products throughout the product development lifecycle and escalate unacceptable risks to management. Prepare reports and summaries for regulatory submissions, audits and internal reviews.

Requirements

BS in Engineering or similar discipline and 12+ years of relevant experience; or equivalent combination of education and work experience.
Acumen in identifying risks through CAPAs, NCMR/NCRs, SCARs, etc., and leading improvements with suppliers, stakeholders and other vendors.
Demonstrated understanding of the audit process including audit planning, preparation, execution, presenting to auditors, reporting results and follow up.
Hands on experience with deep knowledge in terminal sterilization modality (Ethylene Oxide preferred) and understands applicable ISO and guidance documents related to sterility assurance-Sterilization (ISO11135), Microbiology (ISO 11737 series and ISO 11138 series), Cleanrooms (ISO 14644 series, ISO 14698, AAMI TIR 52), Biocompatibility (ISO 10993 series) and Quality Systems (ISO 13485).
Strong knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices.
Excellent communications skills (both written and verbal), with strong ability to review technical documentation and write meticulous, clear and concise procedures.
Strong ability to perform multiple tasks concurrently and accurately.
Proficiency with Microsoft Office products.
Ability to influence others with or without authority at all organizational levels.

Nice To Haves

Master’s degree and catheter, endovascular, or neurological device experience or related regulated industry is preferred.

Responsibilities

Develop and execute quality plans and provide strategic input throughout the product development lifecycle to ensure products comply with regulatory and internal quality systems requirements.
Share data analytics related to quality metrics.
Participate in product development by developing protocols and overseeing quality standards implementation in the design control system.
Provides microbiological, sterilization and biocompatibility technical expertise, when applicable, during new product development activities, process modification studies and failure investigations regarding microbiological contamination control, impact to product and validated sterilization cycles.
Serves as technical liaison with functional groups, contract laboratories and manufacturing sites.
Oversee the Risk Management Report process and contribute to the development of Use Risk, Design Risk and Process Risk documentation.
Collaborate cross-functionally on pilot production of new products and improvement projects.
Establish and maintain quality assurance procedures and educate peers on their use.
Manage relationships with suppliers and testing laboratories by developing quality agreements, assessing performance, troubleshooting failures and creating corrective action plans.
Participate in supplier qualification activities, including on-site audits and evaluations.
When a position’s focus is microbiology, sterilization and biocompatibility, lead all activities and projects related to laboratory selection, compliance audits, along with testing analyses and results interpretation.
Develop and implement sterilization protocols and procedures according to regulations.
Plan and execute validation studies of sterilization and assessments and requalification activities.
Generate Biological Evaluation Plans (BEPs), analyse testing results and assess biocompatibility risks.
Advise on biocompatibility tests to be performed.
Keep accurate/detailed documentation of sterilization test results, methodologies and conclusions.
Provide training and guidance on sterilizations requirements and best practices.
Participate in the maintenance and compliance of quality systems, pre-production/post-production QA procedures, pre-clinical testing programs in coordination with other teams.
Review and assess DCOs, complaints, CAPAs and NCMRs to identify new/revised risks.
Conduct benefit-risk evaluation on products throughout the product development lifecycle and escalate unacceptable risks to management.
Prepare reports and summaries for regulatory submissions, audits and internal reviews.