Supplier Manufacturing Remediation Engineer

Job Title: Supplier Manufacturing Remediation Engineer

Job Location: Maple Grove, MN

Job Type: Contract

Pay Range: $46.00hr - $59.00hr

Job Overview:

The Supplier Engineer will be responsible for remediation activities identified by CAPA for the organization s contract manufactured sourced finished medical device product. The candidate works independently, serves as a leader for supplier engineering remediation activities, and interacts cross-functionally with team members and suppliers to execute deliverables according to business needs.

Top Skills:

• Problem solving, with the ability to showcase examples.
• Manufacturing experience.
• Validation experience.
• Change management experience.

Responsibilities:

• Review, remediate, and approve contract manufactured sourced finished medical device supplier s process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve contract manufactured sourced finished medical device supplier s process and inspection validations to statistical requirements.
• Perform change management activities to remediate gaps found in supplier s process risk documentation and process/inspection validations.
• Collaborate with contract manufactured sourced finished medical device suppliers and functional resources to complete all activities needed to approve supplier s process risk documentation and process/inspection validations to newly defined criteria.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures in all actions.
• Build quality into all aspects of work by maintaining compliance to all Quality System requirements.

Required Qualifications:

• Bachelor s degree in engineering is required.
• 2-5 years of experience in a manufacturing environment.
• Ability to travel up to 15% of the time (domestic possible).

Preferred Qualifications:

• Experience working with suppliers or in supply chain management.
• Experience working in the Medical Device field.
• Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
• Excellent communication and project management skills.
• Strong bias for action and results-oriented mindset.
• Self-driven and self-motivated to learn and apply knowledge to produce results.
• Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities