Director, Quality Assurance and Vigilance

Responsibilities

• Leadership & Organizational Management
• 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.
• Quality Management System Ownership (Site QMS & QMR Role)
• 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 any 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 MedTech where relevant.
• Design Assurance (Full Design Controls Ownership)
• Own and ensure effective implementation of Design Controls (FDA 820.30 / ISO 13485 §7.3).
• Oversee: Design planning, inputs / outputs, and reviews.
• o Verification & Validation
• o 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 deliverables and design changes.
• Ensure design documentation meets FDA 820.30, MDR Annex II/III, and global regulatory expectations.
• Ensure usability engineering (IEC 62366) and software lifecycle considerations (IEC 62304), where applicable, are integrated.
• Participate in and/or chair design governance bodies such as CCB, PRM, and design reviews.
• Design Transfer (Major Emphasis)
• Lead and govern Design Transfer activities from R

Benefits

Additional Information

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 - Ensuring Design Controls and Risk Management are implemented effectively and consistently - Ensuring 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. Salary Range: $185,000-$205,000 - Position is eligible to participate in a bonus plan with a target of 16% of the base salary (include only if applicable to the grade level) - Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. - Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include 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 is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

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