Major Responsibilities
- Knowledge of quality engineering tools – Minitab, SPC programs; DOE, corrective action processes, and PFMEA.
- Support ongoing supplier activities to ensure components are available to support MedVenture’s manufacturing – supplier corrective action, first article inspection (PPAP), etc.
- Certify/recertify suppliers – onsite audits and recertification process.
- Track/monitor supplier performance- quality, cost, delivery, and response.
- Participate in the Material Review Board process for disposition of non-conforming components at MedVenture.
- Assist suppliers in resolving MRB’s and ensuring that defects are identified and corrected.
- Monitor supplier corrective actions and effectiveness.
- Audit supplier quality, process, and business systems per procedural requirements.
- Support supplier and MedVenture purchasing organization with qualifications/validations for process improvements and ongoing cost reductions.
- Support MedVenture’s component ship to stock program and skip lot program.
- Experience with supplier management tools to include performance metrics such as Cpk \ Ppk analysis.
- Negotiations with suppliers.
- Perform other related duties as assigned.
REQUIREMENTS
Job Experience
- Minimum of five years related work experience in Supplier Quality Engineering; preferably business certified to a quality system standard such as ISO 9000, ISO13485.
- Medical Device experience preferred.
- Certified lead quality auditor preferred.
- Experienced in quality systems (ISO 9000, ISO 13485 and/or FDA QSR)
- Experience with Agile PLM software a plus.
- Expert proficiency with Microsoft Office.
Education
- 4 years Engineering degree, or equivalent experience.
- CQE, CQA (ratings), preferred.
Physical Demands
-
Frequent traveling (e.g. supplier audits, projects support)