Hologic Sr. Quality Engineer in Marlborough, Massachusetts
Sr. Quality Engineer
Post Date Feb 15, 2018
Essential Duties and Responsibilities
Provide quality support for new product development activities of medical device products following design control requirements and internal procedures.
Provides general engineering services and support for product manufacturing, quality control and new product development
Compiles and analyzes quality system metrics (e.g. management review, compliance metrics, post market quality assurance, etc.) in order to ensure key process indicators are identified, measured and action driven. Identifies unacceptable trends and drives suitable corrective action
Facilitate and actively contribute to the risk management activities per ISO 14971:2012: Risk Management Plans, FMEA’s, Risk Control, etc. for new and released products.
Supports Materials nonconformance investigation, disposition and release activity as applicable
Write, review and/or approve reports for: test method validations, design verification, design validation, and process validations (IQ, OQ, PQ).
Participate in supplier quality management assessment and qualification as required.
Lead or participate in product, component or assembly qualifications at suppliers.
Write, review and / or approved quality plans to support product activities both internal and external.
Participate in project teams and company initiatives to assure compliance with Quality System requirements while achieving company objectives.
Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)
Perform all other duties as assigned and required.
Some travel may be required (less than 25%).
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.
Strong communication skills, attention to detail and ability to independently seek out information with minimal supervision.
Detail-oriented with strong presentation, communication and organizational skills.
Understands statistical analysis techniques.
Proficiency in MS Office
Excellent technical writing skills.
BS in Engineering or related technical science, M.S. is a plus.
Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality (ASQ) are a plus
- 5+ years of experience as a Quality Professional in the Medical Device industry required.
- Knowledge of ISO 13485 is essential as well as FDA and cGMP regulations and documentation practices
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