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$80k–$125k/yr
Full-time
bachelor degree
Comprehensive training, Career development, Bonus eligible
Posted 4h ago
~40 hrs/week
Responsibilities
The Quality Engineer 2 is responsible for leading validation activities, including analytical methods, equipment, and process qualifications, while ensuring compliance with regulatory standards. They will also provide quality leadership to cross-functional teams, manage risk assessments, and support new product development projects.
Requirements
Candidates must hold a Bachelor’s degree in Science or Engineering and possess at least 2 years of experience in the medical device, biotech, or pharmaceutical industry. Proficiency in validation methods, risk analysis, and knowledge of FDA and ISO regulations is required.
Full job description
The position is responsible for validation activities covering analytical methods, cleaning, production processes, equipment qualification, facilities/utilities qualification, and raw materials qualification.
The role also includes generating and maintaining process FMEA, performing risk assessments for process-related non-conformances and planned deviations, supporting regulatory submissions, writing master validation plans, protocols, and reports, supporting equipment and facilities change controls, and performing validation impact assessments for change orders
Responsibilities
Provide Quality leadership to new product development teams in validation, design transfer, risk management, and specification development.
Author master validation plans and reports.
Author and execute validation protocols and reports for analytical methods, equipment, facilities/utilities, raw materials, process, and cleaning.
Review the quality, validation impact, and completeness of document change order requests and equipment or facilities change controls.
Determine validation strategy using an acceptable risk-based approach.
Lead cross-functional teams to write PFMEAs under limited supervision.
Perform process risk assessments for Non-Conformance Events and planned deviations.
Maintain validation records and support cross-functional teams during New Product Introduction and Sustaining projects.
Review regulatory submissions and notifications under limited supervision.
Propose improvement projects using supporting data and flowcharts.
Assist in updating departmental procedures and controlled documents.
Evaluate specifications for new or modified process designs under limited supervision.
Lead department and cross-department projects, determine QE deliverables, and help create project timelines.
Participate in process design reviews, department process improvements, and department metrics reporting.
Assist Quality Engineering management in Material Review Board and Production Response Team meetings.
Provide management with status updates and escalate issues in a timely manner.
Train new employees.
Knowledge
Bachelor’s degree in Science or Engineering is required.
Working knowledge of CDRH, CBER, and ISO regulations, including 21 CFR Part 820, ISO 13485, and ISO 14971, is required.
Working knowledge of 21 CFR Part 11 is required.
Must follow all applicable FDA regulations and ISO requirements.
Understanding of statistics, SPC, and acceptance sampling is required.
Skills
Proficient in validation methods and evaluation criteria.
Experience with process validation, analytical method validation, cleaning validation, facility/utility qualification, and equipment qualification.
Experience with change control processes and documentation requirements.
Experience with electronic document management systems.
Experience with risk analysis and PFMEA.
Behavior
Demonstrate Quality leadership in cross-functional and new product development settings.
Work under limited supervision when leading PFMEAs, reviewing regulatory submissions, evaluating specifications, and leading department or cross-department projects.
Support collaboration across teams during NPI and Sustaining projects.
Communicate progress to management and escalate issues in a timely manner.
Contribute to continuous improvement through departmental process improvement goals, improvement projects, and metrics support.
Experience
Requires 2+ years of experience in a diagnostic, medical device, biotech, or pharmaceutical company.
Experience should include validation activities, change control, electronic document management systems, risk analysis, and PFMEA.
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 $79,700 - $124,800 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.
Related keywords
Quality EngineerValidationProcess FMEARisk AssessmentRegulatory SubmissionsChange ControlAnalytical MethodsEquipment QualificationFacilities QualificationISO 13485ISO 1497121 CFR Part 82021 CFR Part 11StatisticsSPCAcceptance Sampling
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While we discover and develop groundbreaking products and services that benefit everyone, we are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows and empowers women to experience healthier lives.
None of this would be possible without the talent, skills and aspirations of our employees. Their expertise and dedication to developing and sharing more robust, science-based certainty drives our increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families and communities.
What powers our growth across Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates us: the exceptional and clinically proven ability of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by always challenging ourselves to improve health through better technology, education and market access. Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.
We work toward this goal every day, always aware that in an increasingly complex and competitive global environment, we must continually earn the trust of our customers and their patients. By focusing on women’s health while still delivering health benefits to everyone, we are setting a new standard of excellence that is strengthened by purpose, driven by passion and brought to life by our promise of more certain early detection and better health outcomes.
To view our community guidelines, visit: www.hologic.com/social-media
Offices: 250 Campus Drive, Marlborough, MA 01752, US · 10210 Genetic Center Drive, San Diego, CA 92121, US · Crewe Road, Manchester, England M23 9HZ, GB
Breast & Skeletal HealthDiagnosticand GYN Surgical SolutionsHealth DiagnosticsHealth CareBiotechnologyWomen's
How many Healthcare jobs are open in San Diego, CA right now?
There are currently 3,227 open healthcare positions in San Diego, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in San Diego, CA?
Companies currently hiring include Scripps Coastal Medical Group, Sharp Grossmont Hospital, Kaiser Permanente Oakland Medical Center, Family Health Centers of San Diego, Cheer Home Care, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in San Diego, CA?
Yes — 602 of the 3227 open healthcare positions offer remote or hybrid work (211 remote, 391 hybrid).
How do I apply for Healthcare jobs in San Diego, CA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.