Senior Quality Engineer

Company: Gabriele & Company
Location: Peabody
Posted on: May 13, 2022

Job Description:

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 site.
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 as necessary
Support and/or lead 3rd party audits, including follow-up on actions
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