Senior Director Quality Post-Market Surveillance and Innovation Excellence

6942-ABIOMED Inc. Legal Entity; Danvers (MA); Sur place; USD 178 000 - 307 000; Plein temps

Avantages offerts par ce poste

Retirement plan (pension)

Paid time off

Résumé du poste

The Senior Director, Quality — Post-Market Surveillance and Innovation Excellence at Johnson & Johnson leads enterprise quality strategy supporting the Heart Recovery platform. This role oversees Complaint Management and Post-Market Surveillance, ensuring governance, regulatory compliance, and risk-based decision making across the product portfolio.

Based in Danvers, Massachusetts, this executive partners with Regulatory Affairs, R&D, Manufacturing, and Supply Chain to drive lifecycle quality,

Qualifications

• Bachelor’s degree in engineering, life sciences, biomedical engineering, or related technical discipline; an advanced degree is preferred.
• At least 10 years of progressive quality leadership experience in medical devices or highly regulated industries with responsibility for complaint management and Post‑Market Surveillance.
• At least five years of people leadership directing multidisciplinary quality teams in a complex, matrixed organization.
• Demonstrated expertise in global quality-system and post‑market regulatory requirements (FDA QMSR, 21 CFR Part 820, ISO 13485, EU MDR).
• Proven success leading cross‑functional lifecycle initiatives and integrating design controls, risk management, CAPA, change control, manufacturing, supply chain quality, and post‑market processes.
• Strong ability to translate post‑market data, quality signals, and analytics into risk‑based executive decisions and improvements in patient safety.

Responsabilités

• Translate business priorities into an integrated quality strategy and execution roadmap.
• Oversee Complaint Management and Post‑Market Surveillance with high-performing teams.
• Define capability strategy for Post‑Market Surveillance and Innovation Excellence.
• Collaborate with cross‑functional leaders to align quality with lifecycle objectives.
• Maintain end‑to‑end complaint handling and regulatory reporting.
• Set governance for Post‑Market Surveillance including signal detection and risk assessment.
• Drive corrective actions to reduce repeat events and strengthen safety.
• Lead lifecycle management framework connecting QA processes and supply chain quality.
• Establish cross‑functional decision rights for changes across R&D, Manufacturing and Regulatory.
• Champion quality systems, data governance, and analytics for traceability.
• Maintain inspection‑readiness per FDA QMSR, ISO 13485, EU MDR.

Connaissances

Quality leadership

Executive communication

Cross-functional collaboration

Regulatory knowledge

Strategic thinking

Formation

Bachelor’s degree in engineering or life sciences

Advanced degree preferred

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. Guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Position Summary

The Senior Director, Quality — Post-Market Surveillance and Innovation Excellence is a senior quality executive responsible for shaping and executing the quality strategy that supports the Heart Recovery platform and Innovation Excellence organization. This leader provides enterprise-level direction for Complaint Management and Post-Market Surveillance, with accountability for organizational capability, governance, regulatory compliance, and sustained operational performance. The role establishes an integrated product lifecycle management framework that connects post‑market intelligence with risk management, design controls, change control, CAPA, manufacturing, and supply chain quality to protect patient safety, strengthen product performance, and enable timely, risk-based business decisions across the marketed product portfolio.

Key Responsibilities

• Serve as the senior Quality leader and strategic advisor to the Innovation Excellence organization, translating business priorities, product risk, and regulatory expectations into an integrated quality strategy and execution roadmap.
• Provide executive oversight of the Complaint Management and Post-Market Surveillance organizations, building high-performing, accountable teams through clear priorities, strong governance, talent development, succession planning, and measurable performance objectives.
• Define and advance the organizational capability strategy for Post‑Market Surveillance and Innovation Excellence, ensuring the operating model, expertise, processes, systems, and capacity are positioned to meet evolving business and regulatory needs.
• Partner with Innovation Excellence, Sustaining Engineering, Regulatory Affairs, Research and Development, Manufacturing, Medical Safety, Supply Chain, and Quality Assurance leaders to align quality priorities with platform strategy and lifecycle objectives.
• Maintain accountability for the end-to-end complaint management process, including intake, triage, investigation, root‑cause analysis, trending, escalation, reportability assessment, and timely regulatory reporting.
• Set the strategic direction and governance for Post‑Market Surveillance, including signal detection, risk assessment, cohort analysis, periodic safety reporting, and recommendations for field actions or other risk‑control measures.
• Ensure timely, risk-based evaluation and escalation of post‑market issues; drive systemic corrective and preventive actions that reduce repeat events, improve product performance, and strengthen the overall safety and compliance profile.
• Support the design, implementation, and governance of an integrated lifecycle management framework that connects complaint handling, Post‑Market Surveillance, risk management, design controls, change control, CAPA, manufacturing, and supply chain quality.
• Establish clear cross‑functional decision rights, handoffs, acceptance criteria, and verification strategies for product and process changes across Research and Development, Sustaining Engineering, Manufacturing, Regulatory Affairs, and Quality.
• Champion fit‑for‑purpose quality systems, digital capabilities, data governance, and analytics that provide closed‑loop traceability from field observations through design or process changes and verification of effectiveness.
• Maintain inspection‑ready complaint and Post‑Market Surveillance processes, systems, and records in accordance with FDA QMSR, ISO 13485, EU MDR, and other applicable global requirements.
• Lead executive responses to regulatory inquiries; direct inspection‑readiness activities; and provide quality leadership for regulatory submissions, safety communications, and commitments associated with post‑market findings.
• Establish and communicate meaningful performance indicators, dashboards, and management reviews for complaints, Post‑Market Surveillance, CAPA effectiveness, lifecycle management, and organizational health; use insights to drive prioritization, investment, and continuous improvement.
• Represent Quality in senior leadership forums and influence complex decisions by balancing patient safety, product performance, compliance obligations, operational feasibility, and business continuity.

Required Qualifications

• Bachelor’s degree in engineering, life sciences, biomedical engineering, or a related technical discipline; an advanced degree is preferred.
• At least 10 years of progressive quality leadership experience in medical devices (Class III devices), combination products, or another highly regulated industry, including substantial responsibility for complaint management and Post‑Market Surveillance.
• At least five years of people‑leadership experience directing multidisciplinary quality teams and developing leaders in a complex, matrixed organization.
• Demonstrated expertise in global quality‑system and post‑market regulatory requirements, including FDA QMSR and 21 CFR Part 820, ISO 13485, EU MDR, and applicable vigilance and reporting obligations.
• Proven success leading cross‑functional product lifecycle initiatives and integrating design controls, risk management, CAPA, change control, manufacturing, supply chain quality, and post‑market processes.
• Demonstrated ability to translate post‑market data, quality signals, and analytics into risk‑based executive decisions, strategic priorities, and measurable improvements in patient safety and product performance.
• Strong executive presence and communication skills, with the ability to influence senior stakeholders, navigate ambiguity, lead through change, and clearly communicate complex quality and regulatory matters.

Travel and Work Location: Travel of up to 25% may be required to support company sites, suppliers, and regulatory engagements. The position is based in Danvers, Massachusetts, and is expected to operate in accordance with the applicable flexible‑work arrangement policy.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Preferred Skills

• Compliance Management
• Continuous Improvement
• Corrective and Preventive Action (CAPA)
• Developing Others
• Fact‑Based Decision Making
• Inclusive Leadership
• ISO 9001
• Leadership
• Performance Measurement
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Processes
• Quality Standards
• Standard Operating Procedure (SOP)
• Strategic Thinking
• Succession Planning

The anticipated base pay range for this position is: $178,000.00 - $307,050.00

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year
• for employees who reside in the State of Colorado –48 hours per calendar year
• for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member
• 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52‑week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits