Supplier Quality Engineer

Cypress HCM; Maple Grove (MN); On-site; USD 100,000 - 120,000; Full time

Job summary

A leading medical device company in Maple Grove is seeking a Supplier Quality Engineer to enhance supplier quality throughout the production process. The role involves managing supplier audits, ensuring compliance with quality standards, and driving improvements in supplier performance. This full-time position requires a technical degree and extensive experience in quality management.

Qualifications

• 5+ years in quality management or related fields.
• Lead auditor experience preferred.
• Experience with cardiac medical devices is a plus.

Responsibilities

• Manage supplier audits and performance assessments.
• Negotiate Supplier Quality Agreements.
• Oversee First Article Inspection processes.

Skills

Risk Management

Regulatory Compliance

Quality Assurance

Supplier Management

Statistical Analysis

Education

Bachelor’s degree in a technical field

Tools

ISO 13485

FDA Medical Device Regulation

CE Marking

Job description

A 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 $100,000 - $120,000 annually + bonus and full benefits

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Engineering

• Industries

  Medical Equipment Manufacturing

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