Product Quality Engineer 2

About the role

Provide engineering support for on-market medical devices. Lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance.

Responsibilities

• Lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues.
• Perform data analysis and trend identification to assess risks and recommend mitigations.
• Communicate findings, root causes, and recommendations to stakeholders and leadership.
• Audit product changes for design and risk management impact, ensuring compliance and quality standards are maintained.
• Develop or improve testing methods for complaint investigations and technical activities.
• Collaborate with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements.

Requirements

• 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.
• Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues.
• 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.

Qualifications

• 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.

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.

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.

Pay

The annualized base salary range for this role is $78,000-$122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Schedule

Full-time position.

Benefits

Hologic offers a comprehensive benefits package including health insurance, retirement plans, paid time off, and more. Details can be found in the employee handbook.

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 Department. In 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.

Equal Opportunity Employer

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