Senior Quality Engineer
Company: Katalyst Healthcares & Life Sciences
Posted on: May 29, 2023
- Must have in depth knowledge of and ability to apply quality
system regulation, including QSR, ISO 13485, MDSAP and
MDD/MDR.Apply sound, systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving quality
issues as related to the position responsibilities.
- Contribute to the development of Quality System performance
measures, data collection, trending and reporting. Assures that
data obtained during all quality activities is complete, accurate
and documented consistently with company policies and
- Provide support during Corrective and Preventive Action (CAPA)
activities and manage the CAPA system as necessary.
- Support and/or lead 3rd party audits, including follow-up on
- Lead Back Room, communicate and coordinate associated
activities across the organization.Support Internal Audit program,
e.g., participate/lead Internal audits, follow up on the finding
with auditee through effective closure, present the data for
- Ensure compliance of QMS through authoring and updating
Standard Operating Procedures (SOP).
- Establish and support to client global training program.Support
New Product Development projects, as needed.Other Duties as
assigned Job Qualifications:BS degree is required. MS
- Lead Auditor Certification highly preferred.5+ years Quality
Assurance / Quality Systems experience in an FDA-regulated industry
- Must be proactive and able to work independently with minimal
supervision; strong collaboration skills are essentialKnowledge and
application of QSR/GMP/Google Cloud Platform/ISO regulations as
related to medical device manufacturing.
- Working knowledge and practical application of 21 CFR Part 820,
ISO 13485, and ISO 14971.
- Strong analytical and statistical skillsAbility to Communicate
ideas and information clearly, effectively, and frequently (oral
and written)Ability to exercise judgment to determine methods,
techniques, and evaluation criteria for obtaining results.Able to
work in a fast-paced work environment, prioritize tasks and manage
multiple projects at once.
Keywords: Katalyst Healthcares & Life Sciences, Boston , Senior Quality Engineer, Engineering , Boston, Massachusetts
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