What are the responsibilities and job description for the Manufacturing Quality Engineer position at Micro Tech Staffing - Franklin?
Job Description
Job Description
Overview :
Join a dynamic team as a Quality Engineer and take ownership of critical quality initiatives within an ISO 13485 and FDA-regulated contract manufacturing environment. This role is perfect for a self-motivated professional who leads by example, drives improvements, and ensures compliance with stringent industry standards.
Key Responsibilities :
- Lead Quality Systems Management – Maintain and drive continuous improvement of the Quality Management System (QMS) to ensure compliance with ISO 13485 and FDA regulations.
- Internal Audits – Plan and conduct comprehensive internal audits, identify non-conformances, and implement effective corrective actions.
- Process Validation Leadership – Develop, validate, and oversee manufacturing processes, including creating and executing validation protocols (IQ, OQ, PQ).
- PPAP Activities – Take charge of Production Part Approval Process (PPAP) activities, such as correlation studies, GR&R, and capability analysis.
- Complaint Resolution – Investigate quality issues, lead root cause analyses, and implement corrective / preventive actions (CAPA) to prevent recurrence.
- Regulatory Compliance – Partner with regulatory teams to ensure full compliance with FDA and international medical device standards.
- Supplier Qualification – Evaluate and qualify suppliers to ensure incoming materials meet quality specifications.
- Customer Quality Interface – Address customer inquiries, complaints, and quality improvement requests with professionalism and expertise.
- Documentation Management – Prepare, maintain, and optimize quality documentation, including SOPs, work instructions, and inspection records.
- Data Analysis and Reporting – Analyze quality metrics, generate actionable insights, and recommend enhancements to improve product and process performance.
- Team Training and Mentorship – Train and mentor team members on quality standards, best practices, and regulatory requirements to foster a culture of excellence.
Qualifications :
Company Description
Micro Tech Staffing Group is one of the top staffing firms on the Eastern Seaboard. Since 1985 we have taken great pride in providing quality staffing services to businesses in the fields of Information Technology, Engineering, Manufacturing, Life Sciences, and Finance & Administration. With offices in Massachusetts, New Hampshire, Rhode Island, Connecticut, Maine, Virginia, North Carolina and Georgia, Micro Tech places an average of 2,000 highly-skilled employees daily
Company Description
Micro Tech Staffing Group is one of the top staffing firms on the Eastern Seaboard. Since 1985 we have taken great pride in providing quality staffing services to businesses in the fields of Information Technology, Engineering, Manufacturing, Life Sciences, and Finance & Administration. With offices in Massachusetts, New Hampshire, Rhode Island, Connecticut, Maine, Virginia, North Carolina and Georgia, Micro Tech places an average of 2,000 highly-skilled employees daily