Director, Post Market Surveillance

Hologic • Marlborough, MA • 1w ago

Louisville, CO, United States

Marlborough, MA, United States

Are you ready to lead a high-performing team and make a global impact in the medical device industry? At Hologic, we're passionate about improving lives through innovative healthcare solutions, and we're looking for a visionary leader to drive excellence and continuous product quality improvement.

The Director, Post-Market Quality Engineering will lead a team responsible for driving product quality improvements, investigating complaints, and ensuring regulatory compliance. This role requires strategic leadership to enhance customer satisfaction, build strong cross-functional relationships, and foster a culture of operational excellence.

Knowledge

In-depth understanding of medical device regulations: FDA 21 CFR Part 820, Part 803, ISO 13485:2016, EU MDR, and Canadian MDR.

Engineering principles and methodologies related to product design, manufacturing, and post-market surveillance.

Quality management systems and risk assessments.

Industry trends and advancements in medical device technology.

Skills

Expertise in problem-solving and root cause analysis.

Strong analytical and statistical skills for trend analysis.

Exceptional leadership capabilities to manage and mentor teams.

Clear and effective communication with internal and external stakeholders.

Ability to handle regulatory inspections and compliance reporting.

Experience with Oracle & Agile tools.

PMP Certification.

Lean Six Sigma Green or Black Belt Certification.

Behaviors

Proactive and results-oriented mindset.

Collaborative and team-focused approach to problem-solving.

Ability to foster an engaged, high-performing workplace culture.

Commitment to continuous improvement and operational excellence.

Independent decision-making and prioritization capabilities.

Experience

Minimum 12+ years of experience in the medical device industry or other regulated sectors.

Proven leadership in managing cross-functional teams and driving product quality improvements.

Experience in customer-facing roles and building strong relationships with stakeholders.

Prior management experience in complaint investigations, CAPAs, and regulatory reporting.

The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $167,400-$297,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

LI-NT1

Hologic

Go to Apply

Share this job

Similar Jobs

Family Nurse Practitioner

CVS Health • North Grafton, MA • 32min ago

Hospital & Medical

At CVS Health, we're building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care. As the nation's leading health solutions compan...

32min ago

Go to Apply

Primary Care Nurse

Edward M. Kennedy Community Health Center, Inc. • Framingham, MA • 33min ago

Hospital & Medical

NEW GRAD NURSES ARE ENCOURAGED TO APPLY! Are you looking for a meaningful career? Are you passionate about healthcare in your community? Do you enjoy helping people? The Edward M. Kennedy Community Health Center is one o...

33min ago

Go to Apply

Restaurant Host - Bazille - Natick Mall

Nordstrom • Natick, MA • 58min ago

Retail & Hospitality

Job Description The ideal host/hostess is self-motivated, friendly and committed to providing outstanding customer service every day. A day in the life... Greet and seat customers quickly and in a professional manner Sha...

58min ago

Go to Apply

Customer Service Representative

Rodenhiser Home Services Inc • Holliston, MA • 7h ago

Management & Administrative

At Rodenhiser Home Services, we've built a 90-year legacy on one powerful promise: Nice People. Great Service. And that experience begins the moment the phone rings. The Big Task We're looking for a Customer Service Repr...

7h ago

Go to Apply

Warehouse Associate

Aerotek • Sterling, MA • 7h ago

Manufacturing & Warehouse

Warehouse Associate Job Description As a Reach Truck Operator/Warehouse Worker, you will play a crucial role in ensuring efficient operations by picking orders, delivering materials throughout production, and staging the...

7h ago

Go to Apply

Manufacturing Engineering Internship

Saint-Gobain • Worcester, MA • 19h ago

IT & Engineering

We are currently seeking a motivated and enthusiastic Manufacturing Engineering Intern to join our team for the Summer of 2025. This internship will provide a hands-on experience in various aspects of manufacturing desig...

19h ago

Go to Apply

Construction Manager

Enviri Corporation • Grafton, MA • 19h ago

Trucking & Construction

Clean Earth is a leading provider of environmental services in the United States providing remediation, disposal, recycling, and beneficial reuse solutions for hazardous and non-hazardous waste, contaminated soil, and dr...

19h ago

Go to Apply

Sr. Accountant

Robert Half • Worcester, MA • 1d ago

Finance & Accounting

Description We are looking for an experienced Senior Accountant to join our team in Worcester, Massachusetts. This is a long-term contract position offering the opportunity to lead and enhance accounting operations, prov...

1d ago

Go to Apply

Accounting/Finance Intern

Ameresco • Framingham, MA • 1d ago

Finance & Accounting

Ameresco, Inc. (NYSE:AMRC) is a leading energy solutions provider dedicated to helping customers reduce costs, enhance resilience, and decarbonize to net zero in the global energy transition. We are a trusted, full-servi...

1d ago

Go to Apply

Operations Manager

CVS Health • Shrewsbury, MA • 1d ago

Management & Administrative

1d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.