About the Position:

• Title: Sr. Quality Management Systems Engineer
• Growth potential: Manager of Quality
• Location: My client has two locations that this position can be based at. Northwest outer suburban Boston near Devens or North Central MA about 20minutes west of Fitchburg.
• Compensation: TBD based in experience and fit
• Reports to: Director of Quality & Regulatory
• Reason open: company growth and expansion

Overview:

• 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.
• Position is on-site. No remote. 
• No Visa sponsorship
  

About my Client:

For over 40 years, my client has been a leader in the design and development of components and products for medical and industrial applications.

Required Skills & Experience:

• 6+ years of Medical Device industry experience developing, maintaining and improving Quality Systems.