Product Quality Engineer 3

United States·Newarkmid

OtherProduct Quality Engineer

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Quick Summary

Key Responsibilities

Lead complaint prioritization and investigations based on product risk, data trends, and business impact.

Technical Tools

OtherProduct Quality Engineer

Responsibilities

~1 min read

→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.

Nice to Have

~1 min read

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

What We Offer

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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.

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