Quality Engineer 2

Are you a quality-driven professional with a passion for validation, process improvement, and regulatory excellence? At Hologic, we are seeking a Quality Engineer II to ensure compliance and quality throughout the manufacturing lifecycle of diagnostic and medical device products. In this role, you will lead validation efforts for analytical methods, equipment, processes, and facilities, while also driving risk management and supporting regulatory submissions. You’ll collaborate cross-functionally, contribute to new product introductions, and champion process improvements. If you thrive in a fast-paced environment where you can make a tangible impact on the safety and quality of life-enhancing medical devices, this is the opportunity for you!

Knowledge:

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

Skills:

• Strong technical writing skills for authoring validation protocols, reports, master validation plans, and regulatory submission content.
• Ability to perform validation impact assessments and determine risk-based validation strategies.
• Experience with electronic document management systems.
• Proficient in leading cross-functional teams to develop PFMEAs and address process-related non-conformance events.
• Excellent analytical and problem-solving skills to evaluate specifications and propose improvement projects.
• Strong interpersonal and collaboration skills to work effectively across departments and with cross-functional teams.
• Project management skills, including the ability to determine deliverables, set timelines, and manage departmental or cross-department projects.

Behaviors:

• Detail-oriented and organized with a focus on accuracy and compliance.
• Proactive and solution-oriented, with a continuous improvement mindset to enhance processes and procedures.
• Collaborative team player who fosters strong partnerships across functions.
• Accountable and self-motivated, able to operate with limited supervision and escalate issues as needed.
• Committed to training and mentoring new employees to ensure team success.
• Adaptable and able to manage competing priorities in a fast-paced, regulated environment.

Experience:

• 2–5 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company.
• Hands-on experience with validation activities, including analytical method validation, process validation, and equipment/facility qualifications.
• Experience with regulatory submissions and understanding of quality systems in regulated industries.
• Practical experience with risk management, including PFMEAs and process risk assessments.
• Familiarity with change control processes and electronic document management systems.

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 $78,300-$122,400 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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