Supplier Quality Engineer Assistant
1 month ago
Job Title: Junior Quality Engineer
About the RoleWe are seeking a detail-oriented Junior Quality Engineer to join our team. In this role, you will be responsible for supporting the quality assurance process to ensure compliance with regulatory requirements and industry standards.
Key Responsibilities- Interface with the Quality Lab and Lead SQE to discuss results, document disposition, and obtain required approvals for timely closure of Nonconformance Reports.
- Collaborate with the Lead SQE at weekly Incoming Inspection NCR MRB meetings.
- Communicate failures to suppliers under the guidance of the Lead SQE, request SCARs as necessary, and document the effectiveness of corrective actions.
- Work with Supply Chain to obtain RMA numbers and ensure dispositions are carried out per NCR approval.
- Support the Lead SQE in distributing Scorecards to suppliers.
- Update ASL records in MMC PLM system for new suppliers, Supplier Change Notifications, etc.
- Assist the Lead SQE in setting up meetings with Design Authority and Suppliers.
- Review and approve supplier-initiated changes requests and communicate approved changes through Quality and to relevant departments.
- Gain experience and knowledge by shadowing the Lead SQE in all other activities related to Supplier Quality.
- Bachelor's degree in Engineering or related field.
- At least 2 years of experience in Quality Assurance role or medical device manufacturing company.
- Familiarity with quality audits or supplier audits is an asset.
- Familiarity with ISO 13485:2016 and FDA 21 CFR Part 820 is beneficial.
- Excellent communication and project management skills.
- Ability to work effectively with cross-functional teams.
- Proficient in Microsoft Office.
- Possibility of travel to shadow the Lead SQE during audits or supplier visits.
Estimated annual salary: $68,000 - $85,000.
Location not specified.
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