Duration: 12 Months Contract (Possible Extension) Hybrid - 3 days onsite (required onsite T, W, TH.) MG. Client - MedTechAbout 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.
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.
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.
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