Senior Quality Engineer
Company: Gabriele & Company
Posted on: May 13, 2022
SR. QUALITY SYSTEMS ENGINEER
Our Peabody, MA client seeks a Sr. Quality Systems Engineer that
will be responsible for maintaining the Quality Assurance structure
and ensuring compliance of the Quality Management System (QMS).
This client, an innovative leader in global medical devices, works
relentlessly to promote collaboration, professional development, a
work life balance, and wellness.
The Sr Quality Systems Engineer , using his/her working knowledge
and practical application of 21 CFR Part 820, ISO 13485, and ISO
14971, will be responsible for integrating and maintaining quality
management systems and providing quality system support for the
Key duties and responsibilities:
Support 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 procedures
Provide support during CAPA activities and manage the CAPA system
Support and/or lead 3rd party audits, including follow-up on
Ensure compliance of QMS through authoring and updating Standard
Operating Procedures (SOP)
Essential job qualifications:
BS technical degree
5+ year of experience in Quality Assurance / Quality Systems in an
FDA-regulated industry (Medical device).
Knowledge of QSR/GMP/GCP/ISO regulations specifically applicable
parts of21 CFR Part 820, ISO 13485, and ISO 14971.
Strong analytical, statistical, communication skills
Compensation: $110K (or more depending on education and
experience), performance bonus and a strong benefits package
including health/dental/vision, 401(k) with match, tuition
reimbursement, career growth and more.
Keywords: Gabriele & Company, Peabody , Senior Quality Engineer, Engineering , Peabody, Massachusetts
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