Senior Product Quality Engineer

Hologic • Marlborough, MA

61d • $97,600 - $152,700

About The Position

Are you passionate about ensuring the quality and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role, you'll lead investigations into post-market feedback and complaints, conduct root cause analyses, and implement corrective or preventive actions to ensure our products meet the highest standards of quality and safety. Collaborating with cross-functional teams, you'll drive product and process improvements while making a meaningful impact on the lives of patients worldwide. If you're a proactive problem-solver with experience in quality, risk management, and engineering, we'd love to have you on our team!

Requirements

• Strong understanding of FDA Quality System Regulations, particularly Design Control requirements.
• In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management).
• Familiarity with test method validation, root cause failure analysis, and statistical methods.
• Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components.
• Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards.
• Proven ability to lead cross-functional teams in conducting investigations and implementing corrective and preventive actions (CAPAs).
• Strong analytical skills to prioritize complaints and investigations based on risk, data analysis, and strategic impact.
• Excellent project management skills, including implementing design or process changes, performing testing, and managing change control documentation.
• Ability to perform independent health risk assessments and present findings to leadership.
• Effective communication skills to present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership.
• Strong ability to assess and review written product and project documentation for compliance.
• Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance.
• Proactive and decisive, with the ability to independently prioritize tasks and resolve conflicts.
• Collaborative and team-oriented, with a focus on fostering productive working relationships across functions.
• Problem-solving mindset, focused on identifying root causes and driving effective solutions.
• Customer-focused, with a commitment to addressing product quality issues and ensuring customer satisfaction.
• Driven by continuous improvement, with a desire to optimize processes and enhance product quality.
• 5+ years of experience in engineering, preferably in a regulated industry such as medical devices.
• Hands-on experience with root cause analysis, product development, or R&D.
• Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field).

Nice To Haves

• Experience with verification and validation requirements, design of experiments, and requirements analysis for regulated products.
• Beneficial experience includes supporting complex medical devices (e.g., software, electromechanical systems) at the system level.

Responsibilities

• Lead investigations into post-market feedback and complaints
• Conduct root cause analyses
• Implement corrective or preventive actions
• Collaborate with cross-functional teams
• Drive product and process improvements

Benefits

• 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 $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Number of Employees: 5,001-10,000 employees