Biomedical Resource Consultants, Inc. · 1 week ago
Senior Quality Management Systems Specialist / Engineer
Fitchburg, MA, United States
Full-time
Onsite
Senior Level
6+ years expBiomedical Resource Consultants, Inc. is a leader in the design and development of components and products for medical and industrial applications. They are seeking a Senior Quality Management Systems Specialist / Engineer to maintain and improve the Quality Management System (QMS) in compliance with regulatory requirements and support continuous improvement initiatives.
Staffing & Recruiting
No H1B
Responsibilities
Maintain, improve, and ensure compliance of the QMS in accordance with ISO 9001, ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements
Support continuous improvement initiatives, internal and customer audits, CAPA processes, and documentation control
Develop and maintain QMS documentation including SOPs, work instructions, and related forms and specifications
Train employees to the QMS documentation
Qualification
Required
6+ years of Medical Device industry experience developing, maintaining and improving Quality Systems
Company
Biomedical Resource Consultants, Inc.
Biomedical Resource Consultants, Inc.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
David Leo
Founder & President
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