Staffing - Quality Engineer II - The Fountain Group

The Fountain Group is currently seeking a Quality Engineer II for a prominent client of ours. This position is located in Tewksburg, MA. Details for the position are as follows:

Job Description:

Pay: $45-$51/hour - depending on experience.

Assignment: 12-months - potential to extend or convert based on performance and budget.

In this role, you will:

• Generate, review, and maintain division level quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
• Initiate Change Controls and Document Change Requests to update procedures and processes.
• Collaborate with manufacturing and distribution sites to assess the impact of changes to site level processes.
• Assist with monitoring and assessing quality system metrics to ensure maintained compliance.
• Act as a lead auditor for division internal audit program.
• Assist with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
• Support or leads continuous improvement initiatives for quality management system processes.
• Assist with regulatory activities.

Qualifications:

• Bachelor's degree in engineering or related required
• 3+ years' experience required, or 1+ year and a master's degree required
• ISO 13485 experience required, ISO 9001 preferred.

If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at 813-321-1344

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.