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.

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

• Verification & Validation

• 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&D to manufacturing sites

• Ensure transfer packages are complete, compliant, and support reproducible manufacturing

• Collaborate closely with Manufacturing Engineering and Operations to ensure clarity on specifications, tolerances, verification, and production requirements

• Validate that design intent is preserved during industrialization

• Ensure appropriate documentation is created and approved (DMR elements, specifications, test methods, inspection plans)

• Designing Quality into the Product (DfX)

• Lead the DfX program for the Design Center, ensuring application of:

• Design for Manufacturability (DfM)

• Design for Assembly (DfA)

• Design for Serviceability (DfS)

• Design for Reliability / Durability

• Design for Safety

• Design for Cost

• Ensure cross-functional DfX reviews are structured, documented, and effective

• Drive preventive quality thinking across all NPD teams

• Supplier Quality Management

• Lead Supplier Quality Management for both design and manufacturing phases

• Oversee qualification, auditing, monitoring, and performance evaluation of suppliers critical to product design and lifecycle success, including hand-over to manufacturing sites

• Ensure supplier-related design inputs (components, materials, subassemblies) are clearly defined and controlled

• Support investigations of supplier non-conformances, assess design impact, and drive corrective actions

• Collaborate with global/purchasing SQM for strategic supplier alignment

• NPD & Change Project Leadership (Project Management Emphasis)

• Ensure all New Product Development (NPD) and design change projects follow robust quality planning and design governance

• Serve as Quality leader and steering member for project teams

• Ensure project milestones include Quality reviews, risk updates, and verification/validation completeness

• Approve phase gates, design changes, and technical deliverables from a quality standpoint

• Support project managers with quality planning, risk mitigation, and compliance strategies

• Support to Post-Market Performance (Field Quality)

• Provide technical Quality leadership to complaint handling and product investigations

• Assess whether field issues indicate design gaps or require design enhancements

• Support FAR/MDR technical evaluations (without owning vigilance process)

• Ensure post-market learnings are fed into design improvements, CAPAs, and risk files

• Monitor field performance trends together with PMS and RA

• Support to Manufacturing / Operations

• Though manufacturing is not performed at the Design Center:

• Provide expert technical Quality support to manufacturing sites for issues related to product design

• Contribute to NC/CAPA investigations with potential design root causes

• Ensure designs are manufacturable and adequately transferred to production

• Support DMR content, specification clarity, and design-related manufacturing requirements as needed

• Support supplier investigations related to design inputs or design-relevant components

• Compliance, Audits & Continuous Improvement

• Lead preparation, hosting, and follow-up of audits and inspections (FDA, Notified Body, internal)

• Ensure timely and effective remediation of audit findings

• Monitor and report Quality KPIs; identify trends and drive corrective actions

• Implement systems to ensure ongoing state-of-control and inspection readiness

• Identify and implement improvements to design processes, QMS robustness, and design reliability

• Corrective & Preventive Actions (CAPA) Ownership

• Own and govern the full CAPA process for the Design Center, ensuring compliance with FDA QSR/QMSR, ISO 13485, ISO 14971, and corporate MedTech requirements

• Ensure robust, data-driven root cause analysis using appropriate methodologies (5Why, Ishikawa, FTA, DOE, etc.)

• Ensure CAPAs are timely, effective, and prevent recurrence, applying FOFE ("Find it Once, Fix it Everywhere") principles across products and processes

• Lead cross-functional CAPA reviews with R&D, PMS, Supplier Quality, Manufacturing Sites, and Regulatory Affairs

• Ensure CAPAs linked to post-market issues, complaints, and field performance are escalated and addressed with appropriate design or process actions

• Ensure effectiveness checks are meaningful, documented, and completed according to procedure

• Conduct CAPA trend analysis, identify systemic risks, and drive continuous improvement initiatives

• Prepare the site for FDA and Notified Body scrutiny of CAPA, ensuring documentation is complete, consistent, and inspection-ready

• Ensure CAPA outputs update risk files, design documentation, specifications, and technical files as required

• Quality Culture Leadership

• Build and sustain a culture where Quality is a shared responsibility, and every employee understands their impact on patient safety and product quality

• Drive a Right First Time and Zero Defects mindset, shifting the organization from reactive to preventive behavior

• Promote FOFE ("Find it Once, Fix it Everywhere") to ensure systemic learning and recurrence prevention across all design activities

• Ensure leaders consistently model quality behaviors, demonstrate presence, and reinforce expectations through transparent communication

• Foster a speak-up culture and an environment of trust, where issues are escalated early and treated as learning opportunities, not blame

• Strengthen cross-functional alignment with R&D, PMS, Supplier Quality, Manufacturing, and Market Units to ensure a unified "ONE team" quality mindset across the value chain

• Promote continuous learning, coaching, and quality-driven behaviors, emphasizing that quality culture lives in people, not in procedures

• Ensure quality messages and expectations are connected to the patient impact, reinforcing purpose and accountability

Cross-Functional Collaboration

• Work closely with R&D, Regulatory Affairs, PMS, Clinical, Manufacturing Sites, Market Units, and Global Quality, which can include travel
• Support regulatory submissions with technical documentation and design quality evidence
• Engage with external auditors, regulatory agencies, suppliers, and other Design Centers

Requirements

• Experience with Infusion Pumps, Sets, and Systems preferred but not required
• Over 10 years 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