Overview
Quality Engineer II Jobs in Contoocook, NH at Prototek Digital Manufacturing
Job Summary
We are seeking a dedicated and experienced Quality Assurance Engineer to join our wonderful team.
The ideal candidate would possess the following characteristics and qualifications:
Understanding of Global Regulatory standards (e.g., FDA, ISO 13485, CE marking) and compliance requirements specific to medical devices, ensuring products meet all safety and quality standards.
Certification in Six Sigma (Green Belt, Black Belt, or higher) with proven ability to apply statistical analysis and process improvement methodologies to optimize quality and reduce variation, ultimately improving product reliability and compliance.
Responsibilities:
Provide leadership for Supplier Management to include on-site audits, assessment, approved list maintenance, and updates inclusive of systems and methodologies. Monitor and manage supplier performance metrics, including quality, delivery, and cost.
Conduct thorough inspections of raw materials, components, and finished products. Utilize measurement tools and equipment to ensure products meet specifications. Perform functional and performance testing as required.
Identify and report defects, non-conformances, and deviations from quality standards. Collaborate with production teams to address and resolve quality issues. Monitor and document inspection results and maintain accurate records. Provide complaint analysis, Corrective and Preventive Action System maintenance, and follow through.
Assist in preparing, reviewing, and submitting documents to relevant authorities including the FDA. Maintain and organize regulatory files and records. Ensure timely submission of documents and responses to RA/QA inquiries.
Support the design and execution of Design of Experiments (DOE), validation, and verification activities to ensure product and process performance meet established specifications and regulatory requirements. Collaborate with cross-functional teams to develop test plans, analyze data, and document results for continuous improvement and compliance.
Oversee the maintenance and administration of the Electronic Quality Management System (EQMS) software, ensuring its proper functionality, user access, and alignment with organizational quality standards. Coordinate system updates, troubleshoot issues, and provide ongoing support to users to maintain efficient and compliant processes.
If you are passionate about maintaining high-quality standards and have the skills necessary for this role, we encourage you to apply. Join us in our commitment to excellence!
Job Type: Full-time
Pay: $60,000.00 – $80,000.00 per year
Benefits:
401(k)
Health insurance
Paid time off
Ability to Relocate:
Goose Creek, SC 29445: Relocate before starting work (Preferred)
Work Location: In person
Title: Quality Engineer II
Company: Prototek Digital Manufacturing
Location: Contoocook, NH
