Supplier Manufacturing Remediation Engineer

Cynet Systems • Maple Grove, MN

1d

About The Position

The Supplier Manufacturing Remediation Engineer is responsible for remediation activities identified by CAPA for the organization’s contract-manufactured, sourced finished medical device products. The engineer works independently, leads supplier engineering remediation activities, and interacts cross-functionally with team members and suppliers to deliver work according to business needs.

The role focuses on reviewing, remediating, and approving supplier process risk documentation and process and inspection validations against newly defined and statistical requirements. It also involves change management to address identified gaps. The engineer is expected to maintain compliance with the Quality Policy and documented quality processes and procedures, with a primary commitment to patient safety and product quality.

Requirements

• Bachelor’s degree in engineering.
• 2–5 years of experience in a manufacturing environment.
• Ability to travel up to 15% of the time; domestic travel is possible.
• Problem-solving ability, with examples to demonstrate it.
• Manufacturing experience.
• Validation experience.
• Change management experience.

Nice To Haves

• Experience working with suppliers or in supply chain management.
• Experience 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 a 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.

Responsibilities

• Review, remediate, and approve suppliers’ process risk documentation (PFMEA) for contract-manufactured, sourced finished medical devices against newly defined criteria.
• Review, remediate, and approve suppliers’ process and inspection validations against statistical requirements.
• Perform change management activities to remediate gaps in supplier process risk documentation and process or inspection validations.
• Collaborate with suppliers and functional resources to complete activities required to approve supplier process risk documentation and process and inspection validations against newly defined criteria.
• Maintain compliance with the Quality Policy and documented quality processes and procedures in all actions.
• Maintain compliance with all Quality System requirements and build quality into all aspects of work.
• Lead supplier engineering remediation activities and coordinate with cross-functional team members and suppliers.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level