Manager, Post-Market Quality Engineering

Manager, Post-Market Quality Engineering

Newark, DE, United States Marlborough, MA, United States

Are you a strategic leader with a passion for ensuring product quality and delivering exceptional customer experiences? At Hologic, we are seeking a Manager, Post-Market Quality to oversee product evaluations, root cause investigations, and quality improvement initiatives based on post-market feedback. In this role, you'll lead a team of Quality Engineers, collaborate with cross-functional teams, and act as a customer advocate to address quality concerns and deliver solutions that enhance satisfaction. If you thrive in a fast-paced, customer-focused environment and are ready to drive impactful changes that ensure patient safety and regulatory compliance, this is your opportunity to make a difference!

Knowledge

Comprehensive understanding of regulatory requirements, including 21 CFR Part 820, Part 803, ISO 13485 : 2016, EU MDR, and Canadian MDR.

Expertise in post-market quality processes, including complaint management, adverse event reporting, CAPA, and risk management.

Knowledge of quality tools and methodologies, including root cause analysis, statistical analysis, and trend monitoring.

Familiarity with health risk assessments, design assurance, and post-market surveillance activities.

Awareness of Voice of Customer (VoC) initiatives and their role in quality improvement.

Skills

Proven leadership skills to develop and manage a high-performing team, fostering accountability and collaboration.

Strong analytical and problem-solving skills, including the ability to perform root cause analyses and drive data-driven decisions.

Excellent project management skills, including the ability to prioritize and manage resources effectively.

Exceptional interpersonal and communication skills to build strong relationships with internal teams and external customers.

Ability to translate post-market data and customer feedback into actionable quality improvement initiatives.

Proficiency in preparing and delivering quality reports, metrics, and presentations for management and regulatory reviews.

Familiarity with Oracle, Agile, and quality tools such as Lean-Six Sigma (Green or Black Belt certification is a plus).

Behaviors

Customer-focused mindset, with a commitment to acting as a customer advocate and delivering solutions that exceed expectations.

Operates with urgency and accountability, ensuring timely resolution of quality issues while maintaining compliance.

Collaborative and relationship-driven, building strong partnerships across teams and with customers.

Strategic thinker with a proactive approach to identifying and addressing systemic quality issues.

Committed to continuous improvement, leveraging data and industry best practices to enhance processes.

Adaptable and resilient, managing competing priorities in a fast-paced, regulated environment.

Experience

8+ years of experience with a Bachelor's degree, 5+ years with a Master's degree, or 3+ years with a PhD in engineering, scientific, or a related discipline.

Prior management experience in a medical device, pharmaceutical, or other regulated industry.

Proven success in managing post-market investigations, complaint handling, and quality improvement initiatives.

Experience collaborating with sales, service, and cross-functional teams to address customer concerns and drive improvements.

Beneficial experience includes PMP certification, Lean-Six Sigma certification, and working with capital equipment in healthcare settings.

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 $119,700-$199,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

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