Hologic is seeking a Quality Engineer 3 to provide advanced expertise throughout the manufacturing lifecycle and drive quality initiatives, ensuring compliance and enhancing operational excellence in the medical device industry.
Requirements
- In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP requirements
- Expertise in risk management principles, including ISO 14971 and Process Failure Mode and Effects Analyses (PFMEAs)
- Advanced understanding of statistical tools, including Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE)
- Strong familiarity with Quality Management Systems (QMS) and compliance activities
- Knowledge of lean manufacturing principles and operational excellence practices
- ASQ Certified Quality Engineer (CQE) certificate and/or Six Sigma Certification preferred
- Hands-on experience with statistical tools and lean manufacturing principles to improve process capability
Responsibilities
- Lead investigations, manage validations, and mentor junior engineers
- Ensure robust, compliant processes aligned with regulatory standards and industry best practices
- Manage seamless design transfers to production and product transfers between manufacturing sites
- Analyze quality system metrics and product quality data to identify trends and initiate corrective actions
- Author, review, and approve technical reports for Test Method Validations and Process Validations (IQ, OQ, PQ)
- Implement effective CAPAs and manage Nonconforming Events (NCEs)
- Drive continuous improvement initiatives and optimize processes
Other
- 7+ years of experience as a Quality Professional in the medical device industry or equivalent combination of education and experience
- Proven experience with ISO standards, FDA regulations, and Quality Management Systems
- Demonstrated success in leading CAPA teams, driving investigations, and implementing sustainable corrective actions
- Experience in managing design transfers, production processes, and product transfers while maintaining compliance
- Commitment to compliance, safety, and environmental sustainability while supporting a positive and inclusive work environment
