We are looking for Supplier Manufacturing Remediation Engineer for our client in Maple Grove, MN
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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Benefits
Our Benefits Include:
- 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
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.
