Director, Quality Assurance and Vigilance

Fresenius Kabi USA • North Andover, MA

2d • $185,000 - $205,000 • Hybrid

About The Position

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.

Requirements

• 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.
• 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.
• Excellent communication, collaboration, and project leadership.

Nice To Haves

• Experience with Infusion Pumps, Sets and Systems preferred but not required
• Certification in ASQ or RAPS preferred but not required

Responsibilities

• Leadership & Organizational Management
• Quality Management System Ownership (Site QMS & QMR Role)
• Design Assurance (Full Design Controls Ownership)
• Design Transfer (Major Emphasis)
• Designing Quality into the Product (DfX)
• Supplier Quality Management
• NPD & Change Project Leadership (Project Management Emphasis)
• Support to Post-Market Performance (Field Quality)
• Support to Manufacturing / Operations
• Compliance, Audits & Continuous Improvement
• Corrective & Preventive Actions (CAPA) Ownership
• Quality Culture Leadership
• Cross-Functional Collaboration
• 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.

Benefits

• Position is eligible to participate in a bonus plan with a target of 16% of the base salary
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed