Supplier Quality Engineer (Medical Devices)
Supplier Quality Engineer (Medical Devices)
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Job Description
Role: Supplier Quality Engineer (Medical Devices)
Location: Minneapolis (Arden Hills & Maple Grove) Onsite
Job Type: Contract
Looking for Supplier Quality Engineers with 2 4 years experience in medical device/regulated industries. Must have background in supplier quality QMS CAPA ISO13485/9001 and regulatory compliance. Engineering degree required.
About this role
The Arden Hills Supplier Quality Engineering team is looking for high-energy driven passionate people!
The Supplier QA Engineer will play a key part in leading performance improvement of suppliers and increasing the suppliers capabilities to consistently meet requirements. This role collaborates with cross-functional teams to address and resolve all component-related challenges throughout the supply chain. Additionally the Supplier QA Engineer will support Global Sourcing supplier manufacturing operations and global quality systems by participating in global communities of practice and value improvement projects.
Your responsibilities will include:
- Drives improvement and corrective actions in the quality of components sourced from outside suppliers.
- Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering Manufacturing/Test operations Commercial Sourcing Design Assurance R&D
- Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit
- Plans and organizes non-routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules
- Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives
- Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions
- Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources
- In all actions demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Assures that appropriate resources (personnel tools etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality Systems
Required qualifications:
- BS degree in an Engineering related field such as: Mechanical Engineering Materials Engineering Chemical Engineering Electrical Engineering or similar technical degree with 2-4 years related experience.
- Experience in Quality Management Systems regulatory compliance and risk management.
- Experience with problem solving quality tools Corrective/Preventive Actions (CAPA) Technical Documentation
Preferred Qualifications:
- Experience with or lead auditor certification to ISOTS16949 standards
- Ability to communicate cross functionally with suppliers team members and leadership
- Highly organized and detail-oriented with ability to manage multiple projects and prioritize effectively
Employment Type
Full-time
