Sr Quality Systems Eng
Position Overview
Contribute to maintaining and improving quality systems to ensure compliance with global regulatory requirements and assuring that the quality systems are used effectively 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 in facilitate Quality Systems related discussions. Drive activities related to Quality System improvements. Job duties:
- Maintain CAPA process.
- Partner with 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 analyses, proposing logical and achievable corrective/preventive actions, and following up to ensure actions are effective and completed on time.
- Maintain CAPA records to ensure that they are presentable.
- Support auditing activities and provide leadership for internal audits conducted by Terumo Neuro associates or consultants.
- Support preparation and hosting activities for third-party audits including FDA, Notified Body, and 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 programs.
- Partner with associates in other functions to evaluate and analyze the efforts in organizing, documenting, and making recommendations to management on quality improvement processes.
- 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.
- Identify and escalate critical issues that warrant further actions.
- Create and/or revise procedures to ensure compliance or drive improvement.
- Cross-trained as internal auditor to support Internal Audit process.
- Lead projects and may supervise Technicians, Assemblers, and others as needed.
- 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 five (5) years of quality assurance/compliance related work experience in the medical device industry.
- Must be able to handle multiple projects concurrently and have computer experience and knowledge of FDA Regulations and Application of Good Manufacturing practices.
- Demonstrated understanding of and adherence to Good Documentation Practices.
- Demonstrated experience using investigation techniques and root cause investigation tools, determining appropriate and effective corrective actions, and thoroughly documenting CAPAs.
- Strong interpersonal and verbal and written communication skills; team player with good problem-solving ability.
- Strong analytical skills and attention to detail.
- Successful experience working independently as well as collaboratively, effectively, and confidently in a team environment.
- Ability to partner with associates at various levels within the organization.
- Proficient computer skills, including MS Word, Excel, PowerPoint, Visio, Outlook, and Teams.
- B2 English proficiency.
- Lean Six Sigma, Quality, and/or Project Management related certification, preferred.
- Knowledgeable in 21CFR Part 820, ISO13485, ISO14971, EMDR/MDD, MDSAP and CMDCAS regulations.