Staffing - Quality Engineer II at The Fountain Group
Tewksbury, MA 01876
About the Job
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:
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.
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.
- 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.
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.