- 173940 - Quality Engineer - MA
- 6 months
- Chipton Ross is seeking a Quality Engineer in Acton, MA.
Job Summary: Hill-Rom (Allen Medical) primarily manufactures Class I Medical Devices used for patient positioning in the Operating Room. This role has Operations Quality Engineering responsibility to support the production activities for these products.
o Serves as the primary point of contact for all operational quality related matters in production.
o Identifies, quantifies, and reports on quality performance metrics and trending analysis for Operational Quality.
o Routinely identify and mitigate product/customer risk and supports complaint investigations.
o Deploy efficient and effective corrections to quality problems in a manner that prevents their reoccurrence using our internal listening systems (i.e. Internal Audits, NCEs, and CAPAs).
o Manage the 'Deviation' process.
o Coordinate NCMR process activities: containment activities for defective parts on the floor, investigate potential impacts / risks of part nonconformities and determine nonconforming part dispositions, attend NCMR Meetings and approve NCMR dispositions.
o Create, edit, and approve controlled documents for operations quality processes using document control systems.
o Support manufacturing change control using ECO process. Create, review and approve ECOs as required.
o Review, Revise and approve risk documentation (PFMEA, Risk Plan & Reports)
o Perform periodic review of quality processes used in manufacturing.
o Support Supplier quality management activities. (supplier and part qualifications)
o Coordinate the Ship Hold Process and related documentation.
o Has primary QA responsibility for process validations
o The ability to work under the direction of Operations Quality Manager to resolve quality issues in a dynamic environment while managing priorities day to day.
o Quality engineering medical device experience with strengths in Operational Quality
o Knowledge of QSRs, 21 CFR Part 820, ISO 13485, and ISO Quality System Standards
o Excellent analytical & data decision making with sound problem solving skills with experience using root cause analysis tools.
o Ability to partner & communicate well with internal customers, peers, as well as leadership positions.
o Computer literacy skills in applicable programs (MS Office in Windows OS)
Education and Experience:
o B.S. in Engineering and/or Degree in non-technical field.
o 3-5 years of related medical device / FDA regulated industry quality experience required.
o CQA or CQE desired.
Billy James at firstname.lastname@example.org
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x340 or (800) 927-9318 x340
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.