Quality Engineer, Validation

San Diego, CA, United States

Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.

We are looking for a Quality Engineer responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities/utilities qualification, and raw materials qualification. Additionally, this QE will generate and maintain process FMEA for production processes, perform risk assessments for process related non-conformances and planned deviations, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders.

Roles and Responsibilities

• Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).

• Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).

• Determine validation strategy based on acceptable risk-based approach under close supervision.

• Lead cross-functional team to write PFMEAs under close supervision.

• Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).

• Assist in maintaining validation records.

• Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.

• Propose improvement projects (conceptual).

• Assist in developing/updating departmental procedures and other controlled documents.

• Evaluate adequacy of specifications for new or modified process designs under close supervision.

• Participate in process design reviews.

• Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings.

• Participate in department process improvements goal(s).

• Assist in development, maintenance, and reporting of department metrics.

• Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.

Required Education and Skills

• Bachelor's degree in Science or Engineering with 0 - 2 years of experience in in-vitro diagnostics, medical device, biotech, or pharmaceutical industry

• Proficient in basic validation methods and evaluation criteria.

• Experience with process validation, analytical method validation, cleaning validation, facility/utility and equipment qualifications is preferred.

• Experience with change control process and documentation requirements.

• Experience with electronic document management systems.

• Understanding of statistics, SPC and acceptance sampling.

• Experience with risk analysis and PFMEA is preferred.

• Knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971).

• Knowledge of 21 CFR Part 11.

The annualized base salary range for this role is $73,300 to $114,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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.

If you have the right skills and experience, apply today!

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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.