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 whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION

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 companys 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 futurestate operating model (standard work RACI decision trees global work instructions templates).

• Reduce backlogs / overdue records and improve firsttimeright (FTR) closure quality through lean methods (valuestream mapping waste elimination visual controls) and rightsized 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. intaketotriage time investigation cycle time ontime 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 multijurisdiction 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/98282); 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 postmarket surveillance (PMS) and signal management processes: trending statistical detection benefitrisk 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 highperforming 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 tradeoffs; influence crossfunctional priorities in fastmoving highrisk 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 rootcausedriven 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.

• Bachelors 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 postmarket vigilance (Articles 8792) and PMS integration.

  • MDSAP frameworks with working knowledge across Australia (TGA) Brazil (ANVISA) Canada (SOR/98282) 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 burndown and quality upgrades.

• Strong investigation and technical writing skills (clear problem statements duediligence documentation defensible justifications).

• Executivelevel 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.

• Handson 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 UDIdi 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 endtoend 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:

Our salary ranges are determined by role level and location. Individual pay is determined by several factors including job-related skills experience and relevant education or training. In addition to base pay employees may be eligible for bonus commission equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire Employees are eligible for the following LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.

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