Manufacturing Engineer III

Supplier Engr III

This Supplier Engineer (SE) 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 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 suppliers' process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve CM SFMD suppliers' 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.
• 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.

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.)

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).
• Excellent communication and project management skills.
• Strong bias for action and results oriented.
• 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.