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Fresenius Kabi

Director, Quality Assurance and Vigilance

Salary$185k – $205k
LocationNorth Andover, MA
Work modehybrid
Typefull-time
DepartmentDesign Assurance & Site Quality
Company size10,000+ people
First seen1w ago
Last seen23h ago
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.
Benefits
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
Legal
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.
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
As part of Top Management, you have the overall responsibility and accountability for all aspects of the Health, Safety, Environment, Energy, and Quality Management Systems, including the following:
• Taking overall responsibility and accountability for the prevention of work-related injuries and ill health, the protection of the environment, as well as the provision of safe, harmless, and healthy workplaces,
• Ensuring that the Health, Safety, Environment, Energy, and Quality Management Systems’ policies and related objectives are established and are compatible with the strategic direction of the organization.
Requirements
• Experience with Infusion Pumps, Sets and Systems preferred but not required
• Over 10 year of previous experience and 5 years of experience in managing individuals.
• In depth knowledge of the regulatory environment for medical devices for globally distributed products: 21 CFR Parts 11 and 820, ISO 13485, ISO 9001, ISO 14971, Quality systems expert with knowledge of QSR, ISO, MDSAP, eu- MDR and other relevant regulatory requirements. Ability to develop and manage Quality Systems in compliance with all applicable regulatory bodies.
• The ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
• Demonstrated experience with FDA inspections and Notified Body audits required.
• Strong, practical, and pragmatic knowledge of both US and global Quality system requirements.
• Must have the ability to act as a change agent and drive/influence change as well as effectively lead and motivate team members to achieve goals.
• Certification in ASQ or RAPS preferred but not required
• Strong leadership skills, demonstrated success in managing teams and ability to influence at senior level
• Excellent interpersonal skills with strong written and oral communications.
• Deep expertise in Design Assurance, Design Transfer, DfX, and supplier management.
• Strategic thinker with hands-on, analytical and pragmatic problem-solving skills.
•
The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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