Quality Assurance Specialist
4 days ago
Supplier Remediation Engineer
Advantage Technical is seeking a highly skilled Supplier Remediation Engineer to join our team. As a key member of our supplier engineering team, you will be responsible for remediation activities identified for contract manufactured (CM) sourced finished medical device (SFMD) product.
Key Responsibilities:
- Review and remediate CM SFMD supplier's process risk documentation to newly defined criteria.
- Review and remediate CM SFMD supplier's process and inspection validations to the company'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 the company's functional resources to complete all activities needed to approve supplier's process risk documentation and process/inspection validations to the newly defined criteria.
Requirements:
- Bachelor's degree in engineering or a related field.
- 1 – 2 years of experience in a manufacturing environment.
- Experience working in the Medical Device Field.
- Ability to travel up to 15% of the time.
- Experience working with suppliers or in supply chain management.
- 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.
Preferred Qualifications:
- Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
- Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.
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