Job Description
Job DescriptionA medical device client in Maple Grove is looking to hire a Supplier Quality Engineer to oversees Supplier Quality throughout all stages of production for their cutting edge heart device. This direct hire employee will play an important role in the initial qualification of suppliers and continuously assesses their performance, while functioning as the primary point of contact for suppliers, driving the improvement of quality objectives that meet all company standards.
Duties of Role:
- Manage the Approved Supplier List by employing Risk Management tools, including Hazard Analysis, Design Failure Mode and Effects Analysis, Process Failure Mode and Effects Analysis, and Use Failure Mode and Effects Analysis, to evaluate and determine the criticality of suppliers.
- Organize the Supplier Audit Schedule and conduct supplier audits to assess and improve supplier performance.
- Manage supplier-related Non-Conforming Material Reports by verifying the non-conformance, proposing the material disposition, overseeing follow-up investigations, and coordinating escalations where necessary.
- Oversee the First Article Inspection process ensuring product meets specified quality benchmarks.
- Negotiate Supplier Quality Agreements to maintain quality standards and ensure product consistency from suppliers.
- Oversees Supplier Change Notifications, ensuring timely updates and adjustments.
- Facilitates receiving inspection activities, providing assistance and support as required.
- Directs and manages Supplier Corrective Action Requests, ensuring that suppliers promptly address and rectify any issues or discrepancies.
- Assist in other tasks associated with maintaining a Quality Management System, such as internal audits, standard operating procedure updates, document change reviews, etc.
- Responding effectively to regulatory inquiries related to suppliers and their components.
- Works collaboratively with other departments to identify and assess potential new supplier partners.
Must Haves:
- A bachelor’s degree in a technical field or equivalent experience.
- At least 5 years of experience in quality management, production management, industrial technology or related areas.
- Lead auditor experience is strongly preferred.
- A preference for candidates who bring experience with tissue, transcatheter valve technologies, Nitinol materials, and Laser Cutting techniques.
- Proficient knowledge of and experience working with ISO 13485, Canadian Medical Device Requirements, CE Marking, EU MDR (former MDD), FDA Medical Device Regulation (MDR) and FDA requirements.
- In depth knowledge of manufacturing processes and practices as applicable to the company's products.
- Strong understanding of design controls, risk management, statistics, test method validation, and new product development processes.
- Knowledge of statistics, data collection, analysis, technical report writing and data presentation
Salary of $90,000 - $120,000 annually + bonus and health benefits