Engineer Sr, Quality Systems
Position Overview
As an active, hands-on role, maintain and improve quality systems to ensure compliance with global regulatory requirements and ensure the effective use of quality systems to support company quality policy and objectives. Support the preliminary investigation on CAPA/QAR/audit findings, prepare and analyze reports/metrics, update procedures, and participate/facilitate Quality Systems related discussion. Drive activities related to Quality System improvements. Job duties:
- Maintain CAPA process.
- Partner with the CAPA owners to investigate issues related to audit findings, CAPA and QAR by collaborating with various functions (e.g., R&D, Production, Field Assurance, etc.).
- Facilitate CAPA Review Board meetings, prepare data to be analyzed for CAPAs, and follow up on actions to drive on-time delivery of committed actions.
- Lead and support CAPA owners in understanding and conveying problem statements, conducting thorough root cause investigations and analysis, proposing logical and achievable corrective/preventive actions, and following up to ensure actions are completed on time and effective.
- Maintain CAPA records to ensure that they are presentable.
- Support auditing activities and provide leadership for internal audits conducted by associates or consultants.
- Support preparation and hosting activities for third-party audits including FDA, Notified Body, corporate and international regulatory authorities. Support follow-up efforts.
- Prepare and improve quality system metrics and regularly analyze trends to drive improvement on overall Quality System program.
- Partner with associates in other functions to evaluate and analyze the efforts in organizing, documenting, and making recommendations to management on quality improvement process.
- Develop and conduct quality related training, including CAPA process, conducting root cause investigations, and quality improvement processes.
- Lead the planning and implementation of quality improvement initiatives. 12. Identify and escalate critical issues that warrant further actions.
- Create and/or revise procedures to ensure compliance or drive improvement.
- Crosstrain as internal auditor to support Internal Audit process.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties, as assigned.
- Bachelor's degree in engineering, Science or a related field of study.
- Minimum four (4) years of quality assurance/compliance related experience in the medical device industry.
- Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations and Application of Good Manufacturing Practices.
- Demonstrated understanding of and adherence to Good Documentation Practices.
- Demonstrated use of investigation techniques, root cause investigation tools, determining appropriate and effective corrective actions, and how to thoroughly document CAPAs.
- Strong interpersonal skills, team player with good problem-solving ability, and strong verbal and written communication skills.
- Strong analytical skills and attention to detail.
- Successful experience working independently and collaboratively, effectively and confidently in a team environment.
- Ability to partner with associates at various levels within the organization.
- Proficient with MS Word, Excel, PowerPoint, Visio, Outlook, and Teams.
- Lean Six Sigma, Quality, and/or Project Management related certification, preferred.
- Knowledgeable in 21CFR Part 820, ISO13485, ISO14971, EMDR/MDD, MDSAP and CMDCAS regulations.