Quality Engineer 3

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, youll play a critical role in driving quality initiatives, ensuring compliance, and enhancing operational excellence. Operating with minimal direction, youll lead investigations, manage validations, and mentor junior engineers, all while ensuring robust, compliant processes aligned with regulatory standards and industry best practices. If youre 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 :

Behaviors :

Experience :

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.

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