Director, Post Market Quality

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Director, Post Market Quality is the Quality Management System (QMS) team leader with responsibility to design, implement and oversee quality and compliance improvement and remediation strategies for our global complaints and post market surveillance programs. This role will be responsible for leading a cross-functional team of individuals and partnering with global leaders to develop processes that result in attaining the company’s improvement objectives and growth strategies across Integra manufacturing and design facilities. This leader will oversee process improvements for the end-to-end processes of complaint intake, investigation quality, medical device reportability (vigilance), complaint closure, health hazard evaluations (HHE), and signal detection across two businesses consisting of a diverse portfolio of leading medical devices. The role requires deep knowledge of FDA and MDSAP requirements (Australia, Brazil, EU, Canada, Japan, US) and a proven ability to assess current operations while architecting streamlined, future state processes that are fully compliant, data driven, and resilient to shifting priorities and high-risk areas.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Systems, Process Excellence & Transformation

• Assess current complaint handling and vigilance processes; design and implement a future‑state operating model (standard work, RACI, decision trees, global work instructions, templates).

• Reduce backlogs / overdue records and improve first‑time‑right (FTR) closure quality through lean methods (value‑stream mapping, waste elimination, visual controls) and right‑sized governance.

• Optimize eQMS / CRM workflows (e.g., complaint intake portals, taxonomy, fields, integrations with PMS, Risk, and CAPA); partner with IT on configuration, validation, and analytics.

• Establish and automate leading / lagging metrics and dashboards (e.g., intake‑to‑triage time, investigation cycle time, on‑time regulatory submissions, RPN/criticality trends, recurrence rate, effectiveness).

• Author and maintain enterprise complaint process SOPs / WIs, decision trees for reportability and HHE procedures aligned to multi‑jurisdiction requirements.

Operational Leadership & Compliance

• Owns improvement and leadership of the global complaint lifecycle and teams: intake, triage, investigation rigor, root cause analysis, medical assessment, risk evaluation, reportability assessment, closure, and feedback to design/manufacturing.

• Create a future-state process and leading the team to ensure timely and accurate regulatory reporting/vigilance (e.g., US: 21 CFR Part 803 (MDR); EU MDR 2017/745 Articles 87–92; Canada: Medical Devices Regulations (SOR/98‑282); Australia: TGA reporting; Brazil: ANVISA requirements; Japan: PMDA/MHLW) and maintains auditable documentation and decision rationales.

• Owns process improvements and leadership of the HHE process and team, including strategy, execution, communications, effectiveness checks, and closure packages. Supports the recall process.

• Establishes robust post‑market surveillance (PMS) and signal management processes: trending, statistical detection, benefit‑risk assessment, and escalation pathways to management review and CAPA.

• Partner with Regulatory, Clinical, Medical Safety, R&D, and Supply Chain to ensure embedding of complaint signals into CAPA, risk management (ISO 14971), design controls, and production controls (e.g., ISO 13485 / 21 CFR Part 820 / Part 4 for combination products as applicable).

People & Stakeholder Management

• As process owner and team leader, lead and support a high‑performing global team (complaints specialists, investigators, vigilance/reporting staff); set clear expectations, coach for investigation rigor and writing quality, and develop bench strength.

• Communicate crisply with executive stakeholders on risk, status, and trade‑offs; influence cross‑functional priorities in fast‑moving, high‑risk scenarios.