Quality Engineer

Are you an aspiring quality professional looking to start or grow your career in the medical device industry? At Hologic, we are seeking a Quality Engineer to support validation efforts, risk management, and compliance within our Quality Management System. In this role, you’ll assist with process validations, equipment qualifications, and risk assessments while contributing to cross-functional teams for new product introductions and sustaining projects. If you’re detail-oriented, eager to learn, and excited to contribute to the delivery of life-changing healthcare products, we encourage you to apply and be part of our mission to improve lives worldwide!

Knowledge:

• Foundational understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment/facility qualifications.
• Basic knowledge of risk analysis techniques, such as PFMEA and process risk assessments.
• Familiarity with regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11.
• Awareness of change control processes and documentation requirements.
• Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling methods.

Skills:

• Ability to author and execute validation protocols, master validation plans, and reports under supervision.
• Basic proficiency in electronic document management systems.
• Strong technical writing skills to support regulatory submissions and controlled documents.
• Ability to assist in maintaining validation records and evaluating process specifications.
• Analytical and problem-solving skills to support quality investigations and process improvements.
• Effective collaboration skills to work with cross-functional teams on New Product Introductions (NPI) and sustaining projects.
• Organizational and time management skills to handle multiple tasks and meet deadlines.

Behaviors:

• Detail-oriented and committed to maintaining accuracy and compliance in all tasks.
• Proactive and eager to learn, with a willingness to take on new challenges in a regulated environment.
• Collaborative team player, open to receiving feedback and contributing to shared goals.
• Accountable and reliable, with a focus on timely communication and issue escalation.
• Continuous improvement mindset, with an interest in optimizing processes and proposing enhancements.

Experience:

• 0–2 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company.
• Exposure to validation activities, including process validation and equipment qualification, is a plus.
• Familiarity with Quality Management Systems and regulated environments preferred but not required.

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 $69,000-$101,100 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 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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