Director, Post Market Quality
Integra LifeSciences Corporation, Princeton, NJ, United States
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 lead 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.
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
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
87–92 ) 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 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 $166,750.00 - $228,850.00 USD Salary
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 https://jobs.integralife.com/total-rewards/
Integra 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.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position‑specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
Integra - Employer Branding from Integra LifeSciences on Vimeo
#J-18808-Ljbffr
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 lead 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.
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
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
87–92 ) 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 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 $166,750.00 - $228,850.00 USD Salary
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 https://jobs.integralife.com/total-rewards/
Integra 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.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position‑specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
Integra - Employer Branding from Integra LifeSciences on Vimeo
#J-18808-Ljbffr