Quality Engineer 3 presso 560.5171.0200 THINPREP - DIRECT SALES - SPECIALISTS, US

Are you an experienced quality professional with a passion for delivering excellence in the medical device industry? At Hologic, we are seeking a Quality Engineer 3 to provide advanced expertise throughout the manufacturing lifecycle. As a key liaison between design transfer, production, and continuous improvement, you’ll play a critical role in driving quality initiatives, ensuring compliance, and enhancing operational excellence. Operating with minimal direction, you’ll lead investigations, manage validations, and mentor junior engineers, all while ensuring robust, compliant processes aligned with regulatory standards and industry best practices. If you’re ready to make an impact by delivering safe, reliable, and high-quality medical devices, we want you on our team!

Knowledge:

• 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.

Skills:

• Proven ability to lead root cause investigations, manage Nonconforming Events (NCEs), and implement effective CAPAs.
• Proficiency in analyzing quality system metrics and product quality data to identify trends and initiate corrective actions.
• Expertise in authoring, reviewing, and approving technical reports for Test Method Validations and Process Validations (IQ, OQ, PQ).
• Strong technical writing and communication skills for compliance documentation and stakeholder communication.
• Leadership and mentorship skills to guide and develop junior engineers.
• Effective collaboration and partnership-building skills to work cross-functionally across teams.
• Ability to manage seamless design transfers to production and product transfers between manufacturing sites.

Behaviors:

• Lead with ownership, integrity, and accountability, taking responsibility for outcomes and driving results.
• Act with urgency and maintain a bias toward action, ensuring timely communication and updates.
• Foster strong partnerships and teamwork, investing in relationships with stakeholders to achieve shared goals.
• Delight customers by exceeding expectations and delivering innovative solutions.
• Embrace a continuous improvement mindset, actively seeking opportunities to optimize processes and celebrate wins as a team.
• Commit to compliance, safety, and environmental sustainability while supporting a positive and inclusive work environment.

Experience:

• 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.
• Hands-on experience with statistical tools and lean manufacturing principles to improve process capability.
• ASQ Certified Quality Engineer (CQE) certificate and/or Six Sigma Certification preferred.

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 $83,000-$129,000 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-NT1