Supplier Engineer III # 26-21933

US Tech Solutions; Maple Grove (MN); Híbrido; USD 95.000 - 125.000; Jornada completa

Descripción de la vacante

US Tech Solutions is seeking a Supplier Engineer to own remediation activities for CAPA 7720 related to CM SFMD product. You will work independently, lead SE remediation efforts, and coordinate with BSC teams and CM SFMD suppliers to deliver on business needs.

The role requires a Bachelor’s degree in engineering, 2–5 years of manufacturing experience, and travel up to 15%. The position is Hybrid: three onsite days per week in Maple Grove, MN with remote work as defined.

Formación

• Bachelor’s degree in engineering required.
• 2–5 years of manufacturing experience.
• Ability to travel up to 15% (domestic).
• Experience with manufacturing and validation processes.
• Change management experience required.

Responsabilidades

• Review and approve PFMEA for CM SFMD supplier.
• Review and approve process/inspection validations to client criteria.
• Perform change management to remediate gaps in docs and validations.
• Collaborate with suppliers and client resources to approve docs to new criteria.

Conocimientos

PFMEA remediation

Validation experience

Change management

Six Sigma concepts

Supplier management

Manufacturing environment

Cross-functional collaboration

Educación

Bachelor’s degree in engineering

Descripción del empleo

Duration: 12 Months Contract (Possible Extension)

About the role:

• This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for client contract manufactured (CM) sourced finished medical device (SFMD) product. This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with BSC team members and CM SFMD suppliers to execute deliverables according to business needs.

Responsibilities Include:

• 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 client 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 client functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.

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.)
• Mfg. experience
• Validation experience
• Change management experience

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).
• Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.

Hybrid - 3 days onsite (required onsite T, W, TH.) MG.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement:

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