Job DescriptionIn this role, you'll collaborate with cross-functional teams to lead investigations, implement corrective actions, and support design transfers while leveraging your expertise in regulatory compliance and quality systems. If you're a proactive problem-solver with a strong commitment to operational excellence and customer satisfaction, this is your opportunity to make a meaningful impact on healthcare innovation.
Knowledge:- In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, ensuring regulatory compliance and product quality.
- Strong understanding of risk management principles, including ISO 14971 and PFMEA, to support design transfer and production processes.
- Familiarity with statistical tools and methodologies such as Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE).
- Proficient in Quality Management Systems (QMS), data analysis tools, and enterprise software systems.
Skills:- Proven ability to lead Nonconforming Events (NCE) investigations and CAPA teams to identify root causes, implement sustainable solutions, and maintain compliance.
- Strong technical writing skills for preparing and reviewing technical reports, validation documentation, and quality records.
- Analytical skills to compile, interpret, and act on quality system metrics and product quality data to drive improvements.
- Ability to facilitate design transfers and manage seamless product transitions between sites during New Product Introduction (NPI).
- Proficient in developing and maintaining process FMEAs throughout the production lifecycle.
- Strong communication and collaboration skills to work effectively across teams and with stakeholders.
Behaviors:- Ownership-driven, taking accountability for deliverables and maintaining a proactive approach to resolving quality issues.
- Collaborative and team-oriented, fostering partnerships to achieve shared goals and deliver exceptional results.
- Customer-focused, with a commitment to exceeding expectations and delivering innovative, high-quality solutions.
- Continuous improvement mindset, driving operational excellence and lean thinking across the organization.
- Detail-oriented and compliance-focused, ensuring adherence to regulatory standards, company policies, and best practices.
Experience:- Bachelor's degree in a related discipline or equivalent combination of education and experience.
- 2+ years of experience as a Quality Professional in the medical device industry or equivalent combination of education and experience.
- Hands-on experience with investigations, CAPAs, and process validations (IQ, OQ, PQ).
- Proven success in utilizing statistical tools and methodologies to analyze data and improve processes.
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 NoticeAgencies 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.
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