Product Quality Engineer II

Product Quality Engineer II

Join to apply for the Product Quality Engineer II role at Hologic, Inc.

Are you passionate about ensuring the quality and reliability of life‑saving medical devices? In this role, you’ll lead complaint investigations, perform root‑cause analyses, and implement corrective and preventive actions to improve product quality and compliance. You’ll collaborate with cross‑functional teams, drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction.

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

• 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 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.

• 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.

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required.
• 2–5 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.

We are committed to making Hologic the destination for top talent. The training and development resources we provide enable you to succeed from day one and throughout your career.

Annualized base salary range: $78,000–$122,100, bonus‑eligible. Final compensation depends on experience, skillset, education, business needs, and market demand.

Newark, DE

Agencies that submit a resume must have a current Hologic Agency Agreement executed by a Human Resources member and may only submit candidates to positions for which they have been invited by a Hologic Recruiter. All resumes must be sent to the recruiter under these terms; otherwise they will not be considered.

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

Mid‑Senior Level

Full‑time

Quality Assurance

Medical Equipment Manufacturing