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Hologic Quality Engineer 1 (Validation) in San Diego, California

We are seeking a Quality Engineer I (Validation) to support diagnostic reagent manufacturing validation activities.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

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

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

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

  • Perform process risk assessment for Non-Conformance Events (NCEs).

  • 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.

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Sit; use hands to finger, handle or feel objects, tools, or controls.

  • Exposure to moving mechanical parts, vibration and/or moderate noise levels.

  • Exposure to hazardous chemicals or other materials.

  • Exposure to blood.

Qualifications

Education

  • Bachelor’s degree in Science or Engineering.

Experience

  • 0 - 2 years of experience in a diagnostic, medical device, biotech or pharmaceutical company.

Skills

  • Proficient in basic validation methods and evaluation criteria.

  • Experience with process, method, facility and equipment validation is preferred.

  • Experience with change control systems.

  • Experience with electronic document management systems.

  • Understanding of basic statistics and acceptance sampling.

  • Experience with PFMEAs is preferred.

  • Knowledge of CDRH, CBER and ISO regulations.

  • Knowledge of 21 CFR Part 11.

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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