Overview As Senior Design Quality Engineer, you will support the sustaining and lifecycle management of Sports Medicine Joint Repair products to keep them safe, effective, and compliant. You'll partner with cross functional teams to drive quality improvements and ensure design controls and risk management are applied across the product lifecycle. You'll lead investigations, risk assessments, and quality planning to protect patient safety and product performance. This role offers a chance to influence product quality at scale within a collaborative, patient focused environment. You will shape quality strategy and mentor teams to achieve excellence in compliance and outcomes.
Compensation / Benefits- 401k Matching Program
- Tuition Reimbursement
- Medical, Dental, Vision
- Paid Holidays and Flexible Personal/Vacation Time Off
- Hybrid Work Model
- Parental Leave
Responsibilities- Serve as the Design Quality representative for product support and lifecycle management activities, including improvements, design changes, quality planning, investigations, and quality enhancement initiatives
- Lead risk management activities including risk assessments, FMEA development and maintenance, implementation of risk controls, risk reviews, and verification of effectiveness
- Provide design quality oversight and approval for design verification/validation, sterilization validations, process validations, supplier qualifications, manufacturing process changes, and test methods
- Lead or support investigations related to complaints, nonconformances, CAPAs, post market surveillance, trend analysis, and product risk assessments to identify root causes and drive corrective actions
- Review and approve quality and engineering documentation to ensure compliance with design controls, change control, risk management, and quality system requirements
- Partner with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical, and Supplier Quality to support regulatory submissions, audits, inspections, and ongoing product support
- Act as a quality engineering resource for complex technical and compliance issues, guiding decisions affecting product quality and patient safety
- Identify and drive continuous improvement opportunities through analysis of quality data, product feedback, risk management outputs, and performance metrics
- Provide technical leadership, training, guidance, and mentorship to support decision making, accountability, compliance, and quality excellence
Key requirements- 5+ years of experience in the medical device industry or another highly regulated environment
- Strong knowledge of FDA QSR, ISO 13485, and ISO 14971 requirements
- Experience with risk management, design controls, change control, CAPA, validation activities, and product lifecycle management
- Demonstrated ability to solve complex quality challenges and influence cross functional stakeholders
- Excellent communication, collaboration, and problem solving skills
- CQE and/or Six Sigma certification preferred
- strong communication
- collaboration
- problem solving
- risk management
- design controls
- change control
