Job Description
Job Title: Manufacturing Quality Engineer - Medical Device
Duration: 9+ Months (Possible extension)
Location: Arden Hills, MN 55112
Hybrid Role
Responsibilities:
- The Supplier QA Engineer will play a key part in leading performance improvement of suppliers and increasing the suppliers’ capabilities to consistently meet client's requirements.
- Will support Global Sourcing, supplier manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects
- 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.
- Plans and organizes non-routine tasks with approval.
- Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules
- Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers.
- 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.
Education/Experience:
- BS degree in an Engineering related field, such as: Mechanical Engineering, Materials Engineering, Chemical Engineering, Electrical Engineering, or similar technical degree with 2-3 years related experience.
- Experience in Quality Management Systems, regulatory compliance, and risk management.
- People with Med device QMS preferred or experience working with Manufacturing.
- Experience with problem solving quality tools, Corrective/Preventive Actions (CAPA), Technical Documentation
- Preferred Qualifications:
- Experience with or lead auditor certification to ISO 13485, 9001, TS 16949 standards