Senior Product Quality Engineer

Hologic is dedicated to enabling healthier lives everywhere every dayand the quality of our onmarket medical devices is central to that mission. Were looking for a Senior Product Quality Engineer to lead postmarket product quality efforts by driving complaint investigations root cause analysis and implementation of corrective and preventive this role youll own complex investigations perform health risk assessments lead crossfunctional teams to implement design and process changes and provide datadriven insights that improve product performance in the field. If youre a technically strong proactive engineer who enjoys solving realworld quality issues and partnering across the business this role is for you.

• Working knowledge of FDA Quality System Regulations (21 CFR 820) especially Design Control requirements.
• Familiarity with ISO 13485 EU Medical Device Regulation (MDR) ISO 14971 (Risk Management) GMP and GDP.
• Strong understanding of root cause analysis tools and their application to complaints nonconformances (NCs) and CAPAs.
• Preferred:
  • Knowledge of test method validation root cause failure analysis statistical methods and Design of Experiments (DOE).
  • Familiarity with Reliability Electrical Safety Sterilization Packaging and Biocompatibility standards and requirements.
  • Working knowledge of verification and validation requirements for regulated products.
  • Familiarity with requirements analysis and development of testable measurable specifications.
  • Understanding of riskbased and statistical analysis concepts.

• Ability to lead and own investigations into postmarket complaints including structured root cause analysis and effective stakeholder coordination and communication.
• Strong data analysis skills to trend complaint data and failure modes identify threshold risks propose mitigations and prepare clear summaries for leadership.
• Proven capability to lead crossfunctional teams in implementing improvements or corrections including design and process changes (drawing updates fixtures tooling testing and change control documentation).
• Skilled in developing or improving testing methods used during complaint investigation and root cause activities.
• Proficient in executing and documenting Health Risk Assessments for onmarket products clearly defining problem impact and risk.
• Able to assess product changes for impact on design and risk management and determine the supporting information required for implementation.
• Excellent communication and presentation skills to share product quality metrics explain root causes and recommend actions/resolutions to leadership.
• Comfortable training and supporting complaint intake teams by providing technical expertise for complex investigations.

• Operates with a high degree of autonomy and independence requiring only minor oversight even on complex problems.
• Detailoriented and compliancefocused acting as an advocate for regulatory and quality system requirements in documentation and decisionmaking.
• Proactive and resultsdriven urgently identifying and resolving field quality issues while upholding the Hologic brand image and values.
• Collaborative team player who builds strong relationships with Operations Engineering R&D Sales and Service.
• Analytical and systematic problemsolver committed to identifying true root causes and implementing sustainable corrective actions.
• Confident representing investigations and postmarket quality activities in internal and external audits (facility supplier Notified Body FDA).

• Bachelors Degree in Engineering required (Mechanical Electrical Biomedical preferred).
• 5+ years of experience with a Bachelors degree in Mechanical Biomedical Biomechanical or Electrical Engineering.
• Or 13 years with a Masters degree or 01 year with a PhD in a related discipline.
• Experience in an FDAregulated industry (medical devices strongly preferred).
• Beneficial: Handson experience in root cause analysis product development or R&D particularly for complex devices/systems.
• Experience participating in internal and external audits and inspections is a plus.

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 $97600-$152700and 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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