Medical Device Supplier Engineer - Hybrid, 2-5 yrs Mfg

Integrated Resources, Inc.; Maple Grove (MN); Hybrid; USD 69.000 - 77.000; Vollzeit

Zusammenfassung

Integrated Resources, Inc. seeks a Supplier Engineer (SE) to lead remediation activities for CM SFMD products, focusing on CAPA 7720 compliance.

You will work independently and cross-functionally with CM SFMD suppliers to deliver deliverables that meet business needs and ensure patient safety. The role requires reviewing PFMEA and validation documents, performing change management, and collaborating with suppliers to close gaps to defined criteria while upholding Quality System requirements and

Qualifikationen

• 2–5 years of experience in a manufacturing environment.
• Ability to travel up to 15% of the time (domestic possible).
• Problem solving abilities.
• Manufacturing experience.
• Experience with suppliers or in supply chain management.
• Experience in 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.
• Self-driven and motivated to learn and apply knowledge to produce results.
• Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.

Aufgaben

• Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve CM SFMD supplier’s process and inspection validations to statistical requirements.
• Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
• Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
• In all actions, it 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.
• Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.

Kenntnisse

Problem solving

Manufacturing experience

Travel 15%

Communication

Project management

Self-motivated

Statistical methods

Six Sigma

Jobbeschreibung

Integrated Resources, Inc. seeks a Supplier Engineer (SE) to lead remediation activities for CM SFMD products, focusing on CAPA 7720 compliance.

You will work independently and cross-functionally with CM SFMD suppliers to deliver deliverables that meet business needs and ensure patient safety. The role requires reviewing PFMEA and validation documents, performing change management, and collaborating with suppliers to close gaps to defined criteria while upholding Quality System requirements and