Product Quality Engineer II

Are you passionate about ensuring the quality and reliability of life-saving medical devices At Hologic we are seeking a Product Quality Engineer 2 to provide engineering support for on-market medical this role youll lead complaint investigations perform root cause analyses and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams youll drive process improvements assess risks and deliver impactful solutions that enhance patient safety and customer satisfaction. If youre a proactive problem-solver with a strong background in quality engineering we encourage you to apply and make a difference in healthcare innovation.

Knowledge:

• Strong understanding of FDA Quality System Regulations including Design Control requirements ISO 13485 EU Medical Device Regulation ISO 14971 (Risk Management) GMP and GDP.
• Familiarity with root cause analysis tools risk management principles and compliance frameworks.
• Preferred knowledge of test method validation statistical methods design of experiments (DOE) and industry standards related to reliability sterilization packaging and biocompatibility.

Skills:

• Proven ability to lead complaint investigations root cause analyses and CAPA activities to resolve quality issues.
• Strong data analysis and trending skills to identify risks assess failure modes and recommend mitigations.
• Effective communication and presentation skills to articulate findings root causes and recommendations to stakeholders and leadership.
• Ability to assess product changes for design and risk management impact ensuring compliance and quality standards are maintained.
• Proficiency in developing or improving testing methods for complaint investigations and technical activities.
• Experience collaborating with cross-functional teams including Operations R&D and Engineering to drive product and process improvements.
• Preferred: Familiarity with verification and validation requirements and the development of testable and measurable specifications.

Behaviors:

• Detail-oriented and compliance-focused ensuring adherence to regulatory standards and quality system requirements.
• Proactive and results-driven with a strong sense of ownership for deliverables and outcomes.
• Collaborative and team-oriented building productive relationships across functions to drive quality improvements.
• Customer-focused with a commitment to addressing field quality issues and ensuring timely resolution.
• Continuous improvement mindset driving process optimization and identifying opportunities to enhance product quality.

Experience:

• Bachelors degree in Engineering (Mechanical Biomedical Biomechanical Electrical or related discipline) required.
• 25 years of experience in quality engineering product development or R&D preferably in an FDA-regulated industry.
• Hands-on experience in complaint investigations root cause analysis and CAPA activities.
• Familiarity with internal and external audits including Notified Body and FDA inspections.

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 $78000-$122100 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 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.

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