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Quality Engineer/Validation Engineer 1

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Regulatory & Quality Assurance
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3081 Total Views
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure.
 
There has never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.  Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
 
We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future.
 
We are seeking a Quality Engineer 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.
  • 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.
 
Education       
•           Bachelor’s degree in Science.
 
Experience     
•           Two years of experience in a diagnostic, medical device, biotech or pharmaceutical company.
 
 
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 & VEVRAA Federal Contractor

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