What are the responsibilities and job description for the Supplier Quality Specialist position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Lead the supplier qualification process by assessing manufacturing / technology capabilities.
- Conduct comprehensive gap assessments at target suppliers to identify areas for improvement and create individual supplier development plans.
- Work with suppliers and run SCN and PPAP activity.
- Develop and refine comprehensive training materials to effectively deploy problem-solving, process control, and quality tools.
- Proactively identify and implement continuous improvement activities to prevent the recurrence of non-conformities, ensuring sustained process enhancements.
- Review supplier manufacturing processes and collaborate with suppliers on process improvement and value enhancement opportunities.
- Facilitate root cause analysis and corrective actions of supplier quality issues.
- I independently work with suppliers for the completion of PPAP, Special Process Validation IQ, OQ and PQ requirements.
- Knowledge of International standards relative to QMS, ISO 9001 : 2015, ISO 13485, and ASTM / ASME standards are preferred.
- Strong knowledge of Supplier Qualification, Supplier Production Part Approval Process (SPPA), conducting Product and Process Audit at the supplier end.
- Tailor strategies based on supplier and activity feedback to ensure maximum deployment effectiveness.
- Collaborate with cross-functional teams to develop and enhance the overall supplier development process and phased rollout plans.
- Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers and deliver quality awareness training to suppliers.
- Monitor supplier progress and performance against pre-agreed objectives and goals, providing guidance and support as needed.
Requirements :
