Director, Post Market Quality

Director, Post Market Quality

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.

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, post-market surveillance, 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 8792; 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 Health Hazard Evaluation (HHE) process and team, including strategy, execution, communications, effectiveness checks, and closure packages. Supports the recall process.
• Establishes and manages robust post?market surveillance (PMS) and signal management processes: trending, statistical detection, benefit?risk assessment, and escalation pathways to management review and CAPA.
• Work with various departments to gather post-market data to support documenting PMS reports / periodic safety update reports (PSUR) in accordance with regulatory requirements.
• Responsible for ensuring PMS obligations are in accordance with the applicable regulations ensuring the reports are complete, concise and on time.
• 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.
• Build a culture of quality, compliance, transparency, and continuous improvement with strong accountability.
• Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / system improvements, identify and implement opportunities

Audit / Inspection Readiness

• As process owner, support internal audits and external inspections and audits (FDA, MDSAP Auditing Organizations, Notified Bodies, ANVISA, PMDA, TGA, Health Canada).
• Lead timely and durable responses to observations, ensuring root?cause?driven CAPAs, effectiveness checks, and sustainable controls.
• Perform other related duties as expected.

Minimum Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor's degree in engineering, life sciences, quality, or related scientific field.
• 15+ years in medical device quality, with 10+ years focused on complaints, vigilance / reportability, field actions / recalls, or PMS; 8+ years people leadership.
• Demonstrated expertise with:
• US FDA complaint handling & medical device reporting (21 CFR 803, 820).
• EU MDR post?market vigilance (Articles 8792) and PMS integration.
• MDSAP frameworks with working knowledge across Australia (TGA), Brazil (ANVISA), Canada (SOR/98?282), Japan (PMDA/MHLW), and US (FDA).
• ISO 13485:2016 and ISO 14971:2019.
• Proven track record running and improving complaint/vigilance processes at scale, including backlog burn?down and quality upgrades.
• Strong investigation and technical writing skills (clear problem statements, due?diligence documentation, defensible justifications).
• Executive?level communication skills; adept at risk storytelling and prioritization under ambiguity.
• Experience leading and/or supporting recalls/field actions.

Preferred Qualifications

• Graduate degree (MS, MBA, MEng, RN) or RAC, ASQ (CQE, CMQ/OE, CQA), or ISO 13485 Lead Auditor certification; Lean / Six Sigma certification.
• Hands?on experience with leveraging the use of Artificial Intelligence (AI) as well as eQMS / CRM (e.g., TrackWise, MasterControl, Veeva, ServiceNow, Salesforce) and analytics/BI tools.
• Familiarity with UDI, UDI?di traceability, and global distribution / field action logistics.
• Experience integrating PMS with risk files, clinical evaluation/PMCF (where applicable), and Design Controls.
• Experience leading recalls/field actions end?to?end and presenting to regulators/auditors.

Additional Qualifications

• Strong oral and written communication skills and effective interpersonal skills.
• Strong experience leading the deployment of enterprise quality management solutions.
• Experience in FDA-regulated environment.
• Strong collaboration skills and experience working in a matrix environment.
• Ability to interface with technical and non-technical personnel.
• Ability to multitask, prioritize and meet deadlines.
• Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.) is required.
• This position could require up to 25% travel.

Salary Pay Range: