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.

• Ensures adequate technical support to Post Market Surveillance, field performance investigations, and manufacturing issues for all products designed at the center.
• Ensures Design Controls and Risk Management are implemented effectively and consistently.
• Ensures the site is continuously prepared for FDA inspections, Notified Body audits, and internal audits.
• Ensures product designs are safe, effective, manufacturable, and compliant throughout their lifecycle, and that quality culture and performance meet Med Tech 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 Med Tech business.

Salary Range: $185,000-$205,000

• Position eligible to participate in a bonus plan with a target of 16% of the base salary.
• Final pay determinations depend on experience level, education, and skills.
• Benefits include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits such as medical, prescription drug, dental and vision coverage.

Hybrid role:
Onsite 3 days per week.

Applicants must be authorized to work for any employer in the United States;
Fresenius Kabi will not sponsor or assume sponsorship of an employment visa either now or in the future.

• Appointed as Management Representative for the North Andover Design Center with responsibility and authority.
• Lead the site Quality organization, including Design Assurance, Quality Systems, Compliance, and related functions.
• Create vision, strategy, and priorities for the site Quality team aligned with Global Quality, R&D, and business needs.
• Mentor, coach, develop, and evaluate team members; promote behaviors aligned with right‑first‑time execution, early risk identification, continuous improvement and timely escalation of quality issues.

• Ensure processes required for the QMS are defined, documented, implemented, and maintained.
• Ensure awareness and understanding of applicable regulatory, customer and quality requirements across the site.
• Report regularly to top management on QMS performance, risks, and improvement needs.
• Maintain site certification(s) and compliance with ISO 13485, MDR, FDA QSR/QMSR, ISO 14971, and other applicable standards.
• Lead site readiness and execution for FDA inspections, Notified Body audits, corporate audits, and internal audits.
• Oversee document control, training effectiveness, internal audit program, CAPA system, change control, and management reviews.
• Drive continuous improvement, implementing best practices and harmonization across Med Tech where relevant.

• Own and ensure effective implementation of Design Controls (FDA 820.30 / ISO 13485 § 7.3).
• Oversee design planning, inputs/outputs, and reviews.
• Ensure verification & validation.
• Ensure design transfer and design changes.
• Ensure products are designed for safety, efficacy, quality, manufacturability, usability, and compliance.
• Ensure comprehensive application of ISO 14971 Risk Management, including risk file maintenance and post‑market risk evaluation.
• Provide independent Quality approval for design…