Senior Quality Engineer I

Integra LifeSciences•Mansfield, MA

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Sr. Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The individual will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. The individual will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business and supervise, lead and mentor other engineers and technicians.

Requirements

Bachelors degree or equivalent with 8+ years of experience, Masters degree with 5+ years experience, Doctoral degree with 3+ years experience
Experience working in manufacturing/operations
Knowledge in Risk Management (FDA and ISO standards)

Responsibilities

Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close).
Work with third party supplier to resolve issues with NC.
Conduct Internal/Supplier Audits of the facility per ISO-1385 and/or 21CFR820
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints.
Escalation of quality issues as appropriate.
Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
Analyze/review effectiveness of preventive and corrective actions.
Review root cause investigation according to an established process.