Supplier Remediation Engineer
2 weeks ago
This Supplier Remediation Engineer will be responsible for the remediation activities identified by CAPA 7720 for BSC's contract-manufactured (CM) sourced finished medical device (SFMD) product.
This individual works independently, serves as a leader for remediation activities, and interacts cross-functionally with BSC team members and CM SFMD suppliers to execute deliverables according to business needs.
Key Responsibilities:
- Review, remediate, and approve CM SFMD supplier's process risk documentation to newly defined criteria.
- Review, remediate, and approve CM SFMD supplier's process and inspection validations to BSC's 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 BSC functional resources to complete all activities needed to approve supplier's process risk documentation and process/inspection validations to the 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.
Requirements:
- Bachelor's degree in engineering or a related field.
- Years of experience in a manufacturing environment.
- Ability to travel up to 15% of the time.
Preferred Qualifications:
- 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.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.
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 learn more about US Tech Solutions, please visit our website.
US Tech Solutions is an equal opportunity employer and welcomes applications from diverse candidates.
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