Product Quality Engineer 2

DIRECT SALES, US; Newark (DE); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic is seeking a Product Quality Engineer 2 to support on-market medical devices. You will lead complaint investigations, perform root cause analyses, and drive corrective and preventive actions to improve product quality and compliance.

Responsibilities include collaborating with Operations, R&D, and Engineering to mitigate risks, enhance patient safety, and ensure regulatory adherence. The role emphasizes data-driven decisions and effective communication with stakeholders.

Qualifications

• Bachelor's degree in Engineering required.
• 2–5 years of experience in quality engineering, product development, or R&D in FDA-regulated industry.
• Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
• Familiarity with audits, Notified Body and FDA inspections.

Responsibilities

• Lead complaint investigations and CAPA activities to resolve quality issues.
• Perform root cause analyses and implement corrective actions.
• Develop or improve testing methods for investigations and technical activities.
• Collaborate with cross-functional teams to drive product and process improvements.
• Assess design changes for risk management impact and regulatory compliance.

Skills

Complaint investigations

Root cause analysis

CAPA management

Data analysis

Risk assessment

Cross-functional collaboration

Communication skills

Regulatory compliance

Testing method development

Education

Bachelor's degree in Engineering

Job description

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 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. Collaborating with cross-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction.

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:

• 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.

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 $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.

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

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