Director, Quality Assurance and Vigilance

Job Summary The Director of Design Assurance & Site Quality is the senior quality leader for the Design Center and responsible for leading and developing the local Quality organization. This role leads the local Quality organization, owns and maintains the Design Center's QMS, and serves as the Site Quality Management Representative. As the owner of Design Quality, the Director ensures that all products developed at the site meet applicable regulatory, compliance, safety, and performance requirements throughout their lifecycle. The role provides leadership in Design Controls, Risk Management, DfX, Design Assurance, Design Transfer, Supplier Quality, Technical Documentation, and Audit/Inspection Readiness. The Director ensures design robustness, manufacturability, and continuous improvement, while also ensuring adequate technical support to Post Market Surveillance, field performance investigations, and manufacturing issues for all products designed at the center. The Director ensures Design Controls and Risk Management are implemented effectively and that the site is continuously prepared for FDA inspections, Notified Body audits, and internal audits. The Director ensures that product designs are safe, effective, manufacturable, and compliant throughout their lifecycle, and that quality culture and performance meet MedTech standards. This leader is a key member of the Design Center Management Team and the BU Quality Leadership Team, collaborating cross‑functionally with R&D, PMS, Regulatory Affairs, Manufacturing Sites, Supplier Quality, and Market Units across the MedTech business. Hybrid role: Onsite Tues, Wed, Thurs. Salary Range: $185,000-$205,000.

Responsibilities

Leadership & Organizational Management

Appointed as Management Representative for the North Andover Design Center with responsibility and authority.

Lead the site Quality organization, including

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