Key skills
Risk ManagementCommunicationCollaboration
About this role
Role Overview
- Lead quality engineering guidance and oversight for medical devices and combination products during feasibility, design control, risk management, and lifecycle management.
- Define critical quality characteristics for device components and finished devices in collaboration with the device development team.
- Support internal and external audits as a device or combination product Subject Matter Expert.
- Oversee the quality review and approval of technical documentation, ensuring compliance with regulatory requirements.
- Provide input to process manufacturing design and design transfer for robust product realization.
- Support asset team strategies for regulatory filings, design control, and risk management.
- Lead continuous improvement initiatives for the Quality Management System and lifecycle processes.
- Function as the quality representative on cross-functional initiatives and device development programs.
- Manage quality assurance interfaces with medical device suppliers and testing partners in collaboration with External Quality.
Requirements
- Minimum of a BS in Biomedical/Mechanical Engineering or related technical or scientific discipline.
- At least 7 years of experience in medical device and/or combination product industries.
- Extensive knowledge of design control and risk management for medical devices.
- Strong understanding of regulatory requirements and quality standards.
- Excellent communication and collaboration skills.
- Proven ability to lead cross-functional teams and initiatives.
- Experience in leading continuous improvement initiatives within a Quality Management System.
- Familiarity with medical device supplier and testing partner management.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short
- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation