Job DescriptionThe Quality Engineer II supports product and process quality within regulated environments such as medical device, biotech, or pharmaceutical manufacturing. The role focuses on validating processes, equipment, analytical methods, and facilities to ensure compliance with FDA and ISO regulations. The engineer also supports risk management activities, change controls, regulatory submissions, and cross-functional product development efforts while maintaining validation documentation and quality systems.
Essential Duties and Responsibilities
- Provide quality and validation leadership to new product development teams, including support for design transfer, risk management, and specification development.
- Develop and maintain master validation plans, validation protocols, and validation reports.
- Execute and document validation activities including analytical method validation, equipment qualification, facility/utility qualification, process validation, cleaning validation, and raw material qualification.
- Review document change orders and change control requests for completeness, quality impact, and validation impact.
- Determine validation strategies using a risk-based approach.
- Lead or support cross-functional teams in developing and maintaining Process Failure Mode and Effects Analysis (PFMEA).
- Conduct risk assessments for process-related non-conformances and planned deviations.
- Maintain validation documentation and records.
- Support New Product Introduction (NPI) and sustaining product projects.
- Review regulatory submissions and notifications as needed.
- Identify and propose process or quality improvement projects using supporting data and analysis.
- Develop or update departmental procedures and controlled documents.
- Evaluate the adequacy of specifications for new or modified process designs.
- Lead departmental and cross-functional projects, define deliverables, and support project timelines.
- Participate in process design reviews.
- Support Material Review Board (MRB) and Production Response Team (PRT) meetings.
- Contribute to departmental process improvement initiatives and quality metrics.
- Provide regular status updates to management and escalate issues when necessary.
- Train new employees.
Knowledge
- Validation principles for analytical methods, processes, cleaning, equipment, facilities, and utilities.
- Risk management methodologies including PFMEA and risk assessments.
- Statistical concepts such as Statistical Process Control (SPC) and acceptance sampling.
- Change control systems and validation impact assessment.
- Regulatory requirements including FDA regulations (21 CFR Part 820, Part 11), ISO 13485, ISO 14971, and familiarity with CDRH and CBER expectations. Quality systems and electronic document management systems used in regulated industries.
Skills
- Ability to develop validation strategies using risk-based approaches.
- Strong documentation and technical writing for protocols, reports, and regulatory documentation.
- Analytical and problem-solving skills for investigating deviations and non-conformances.
- Cross-functional collaboration with engineering, manufacturing, quality, and regulatory teams.
- Data analysis and interpretation using statistical tools.
- Project coordination and timeline management.
Behavior
- Detail-oriented with a strong focus on compliance and documentation accuracy.
- Collaborative mindset for working with cross-functional teams.
- Proactive in identifying risks and improvement opportunities.
- Strong communication skills for reporting progress and escalating issues.
- Ability to work with limited supervision and manage multiple responsibilities.
- Commitment to regulatory compliance and continuous improvement.
Experience
- Bachelor's degree in Science or Engineering.
- Two to five years of experience in a regulated industry such as diagnostics, medical devices, biotechnology, or pharmaceuticals.
- Practical experience in validation activities, risk analysis, and quality systems within FDA and ISO regulated environments.
- Familiarity with change control systems, validation documentation, and electronic document management systems.
- Working knowledge of applicable FDA and ISO standards and regulatory requirements.
The annualized base salary range for this role is $79,000 - $124,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
#LI-AV1
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.
