Job description

Hologic is a global medical technology company focused on women’s health and wellbeing. Our Newark, Delaware team manufactures the 3Dimensions Mammography System, recognized as the “Coolest Thing Made in Delaware,” which helps detect breast cancer earlier and with greater certainty. Join a high-growth, world-class manufacturing facility producing life-saving medical devices. Job Summary: Product Quality Engineer will make a direct impact on patient safety and product excellence by serving as a key quality partner for on-market medical devices. In this role, you will investigate product performance issues and customer complaints, conduct risk assessments and root cause analyses, and drive data-based solutions that enhance product quality and reliability. Collaborating across Engineering, Manufacturing, Regulatory, and Quality teams, you will lead cross-functional efforts to implement corrective and preventive actions, ensuring continuous improvement and compliance throughout the product lifecycle. This is an opportunity to influence meaningful change while helping deliver high-quality medical devices that improve patient outcomes. Key Responsibilities In addition to other duties as business needs require, the Product Quality Engineer will: • Lead complaint prioritization and investigations based on product risk, data trends, and business impact. • Conduct root cause analyses and coordinate cross-functional teams to drive timely resolution of quality issues. • Perform health risk assessments and evaluate product performance concerns for on-market medical devices. • Partner with Quality, Operations, Engineering, R&D, Regulatory, and Manufacturing teams to determine corrective and preventive actions (CAPAs) and implement product or process improvements. • Analyze and trend complaint and failure mode data, identify emerging risks, and present findings and recommendations to stakeholders and leadership. • Manage design and process change projects, including testing, documentation, change control, and implementation activities. • Develop and enhance investigation and testing methods to improve problem-solving effectiveness. • Provide technical guidance and training to complaint handling and support teams. • Assess the impact of product changes on design controls and risk management requirements. • Partner with field-based teams to investigate customer-site quality issues and ensure timely resolution. • Present quality metrics, investigation outcomes, and recommendations to leadership and review boards. • Support internal and external audits, including supplier audits and regulatory inspections. • Apply professional expertise to independently resolve complex quality issues while contributing to continuous improvement initiatives. Skills • Working knowledge of FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP • Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution • Ability to appropriately assess written product and project documentation as an advocate for compliance, and ability to effectively communicate assessment • Strong knowledge of root cause analysis tools and ability to lead root cause activities for complaint investigations, NCs, CAPAs, etc. • Excellent communication and presentation skills • Works with high degree of autonomy and independence, requiring minor oversight on complex problems with analysis requiring a variety of factors. Preferred Skills • Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment • Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements. • Working knowledge of verification and validation requirements for a regulated product • Familiarity with requirements analysis, including development of testable and measurable specifications • Knowledge of risk based and statistical analysis concepts Compensation The annualized base salary range for this role is $85,300- $133,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-MP3

Requirements

Must-haves

Join a high-growth, world-class manufacturing facility producing life-saving medical devices.
In addition to other duties as business needs require, the Product Quality Engineer will:
Lead complaint prioritization and investigations based on product risk, data trends, and business impact.
Conduct root cause analyses and coordinate cross-functional teams to drive timely resolution of quality issues.
Perform health risk assessments and evaluate product performance concerns for on-market medical devices.
Partner with Quality, Operations, Engineering, R&D, Regulatory, and Manufacturing teams to determine corrective and preventive actions (CAPAs) and implement product or process improvements.
Analyze and trend complaint and failure mode data, identify emerging risks, and present findings and recommendations to stakeholders and leadership.
Manage design and process change projects, including testing, documentation, change control, and implementation activities.
Develop and enhance investigation and testing methods to improve problem-solving effectiveness.
Provide technical guidance and training to complaint handling and support teams.
Assess the impact of product changes on design controls and risk management requirements.
Partner with field-based teams to investigate customer-site quality issues and ensure timely resolution.
Present quality metrics, investigation outcomes, and recommendations to leadership and review boards.
Support internal and external audits, including supplier audits and regulatory inspections.
Apply professional expertise to independently resolve complex quality issues while contributing to continuous improvement initiatives.
Working knowledge of FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP
Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
Ability to appropriately assess written product and project documentation as an advocate for compliance, and ability to effectively communicate assessment
Strong knowledge of root cause analysis tools and ability to lead root cause activities for complaint investigations, NCs, CAPAs, etc.

Nice-to-haves

Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment
Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
Working knowledge of verification and validation requirements for a regulated product
Familiarity with requirements analysis, including development of testable and measurable specifications
Knowledge of risk based and statistical analysis concepts

Application prep

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Platform: oracle-cloud
Effort: medium