Are you an experienced Manufacturing Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Manufacturing Engineer to work at their company in Maple Grove, MN.
Position Summary: This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for the client'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.
Primary Responsibilities/Accountabilities:
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 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 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, 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.
Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.
Qualifications:
Bachelor's degree in engineering or a related field.
1 - 2 years of experience in a manufacturing environment.
Ability to travel up to 15% of the time.
Preferred:
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.