Quality Manager - Design Assurance

Manager of Design Quality and Risk functions within Infusion platform. Leads and manages all quality activities related to the design, development, and transfer of medical devices to manufacturing.

Requirements

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or a scientific discipline.
• Minimum of 8 years of experience in Quality Assurance within the medical device industry, with at least 2-3 years in a leadership or management role focused on Design Assurance.
• Extensive knowledge and practical application of medical device regulations and standards, including FDA 21 CFR Part 820 (QSR), ISO 13485, ISO 14971, and EU Medical Device Regulation (MDR).
• Demonstrated experience with product development, design controls, and design verification/validation methodologies.
• Expertise in product risk management and hands on experience developing and maintaining a Product's Risk Management File.
• Proven ability to recruit, lead, motivate, and develop a team of quality professionals.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex technical and regulatory information.
• Experience with various quality tools and methodologies (e.g., FMEA, SPC, Root Cause Analysis).
• ASQ certifications (e.g., CQE, CMQ/OE, CRE) are highly desirable.

Benefits

• Competitive salary and benefits package
• 401k Matching
• Retirement Plan
• Generous Paid Time Off
• Tuition Reimbursement
• Relocation Assistance