Product Quality Engineer 2

Detail | Hologic Skip to main content Skip to main menu tabs for megamenu Skip to sitemap

Region

Choose region

North America Latin America EMEA APAC

Language

EN

Chinese, SimplifiedDutchEnglishFrenchGermanItalianJapanesePortuguese, PortugalPortuguese, BrazilSpanish

Search jobs

Product Quality Engineer 2

Newark, DE, United States

Join our talent community Share Apply

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. If you're 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:

• 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.

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.

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

#LI-MP3

Apply now

Similar jobs

Lead Software Engineer, Full Stack Featured

Newark, DE, United States, US, DE Employee

Hologic is the market leader in mammography, but we're always building for what's next. Join us in Newark, DE and help shape the future of Breast and Skeletal Health-developing products that are innovative ...

View details

Senior Software Engineer, Medical Device Featured

Newark, DE, United States, US, DE Employee

Located in Newark, DE,Hologic's Innovation Center is continuing to offer job opportunities. We are seeking aSenior Software Engineer (C#/ .NET, Full Stack)to design, develop, troubleshoot, and debug software for new and ...

View details

Senior Embedded Software Engineer Featured

Newark, DE, United States, US, DE Employee

We're looking for aSenior Embedded Software Engineer to design, develop, and maintain embedded software for our next-generation breast and skeletal health systems.In addition to core embedded software development ...

View details

Senior Electrical Engineer, NPD Featured

Newark, DE, United States, US, DE Employee

Hologic's Breast & Skeletal Health division is hiring aSenior Electrical Engineer, NPD to help design and advance the electronics behind our industry‑leading imaging systems. In this role, you'll work ...

View details

Back to search result

• Hologic.com
• Products
• About
• Hiring Scam Warning

Region

Choose region

North America Latin America EMEA APAC

Region

Choose region

North America Latin America EMEA APAC

Contact

Privacy Policy

Terms & Conditions

Patent Info

2021 Hologic Ltd. All rights reserved.