- Growing Medical Device Manufacturer
- Recently launched a new product
About Our Client
Our client is a rapidly growing global biotech company, who provide over 30 years of expertise and innovation to their customers.
- Effectively partner with suppliers to ensure materials, components and services conform to specifications and quality standards.
- Complete supplier assurance activities to ensuring compliance to QMS standards and applicable regulations.
- Act as Lead Auditor during supplier audits, onsite or virtually.
- Systematically monitor risk in supply chain through the supplier qualification process, ongoing evaluations/monitoring, onsite/virtual assessments, and supplier performance metrics.
- Review and approves supplier records: contracts, quality plans, change requests, CAPAs, NCRs, verification and validation protocols and reports.
- Support supplier performance to ensure supplier's capabilities consistently meet standards and regulations.
- Communicate quality issues, evaluate proposed changes at suppliers, and support change management.
- Support Quality Management Team in establishing, implementing, and maintaining the quality management system for ISO 9001.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- Bachelor's degree in an engineering or scientific discipline.
- Relevant experience in quality engineering or supplier quality auditing, including experience in the life sciences or medical device industry.
- ISO 9001 Quality Management System experience.
- Knowledge of CGMP
- Experience with manufacturing support or process development.
- Experience with project management tools.
- Demonstrated experience auditing quality systems.
- Knowledge and experience in trend analysis, problem-solving/process improvement techniques, and Root Cause Investigation/CAPA.
What's on Offer
Our client offers a competitive base salary, bonus, and benefits. Once you apply, I will reach out and share more information.