Location: all cities,MA, USA
Title : Supplier Quality (Medical Device specialist)
Location : Tijuana, MX and GUAYNABO, PR and MA, USA and MN, USA
• 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.
• 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.
Qualification:
• Bachelor's degree in engineering B. Tech / B.E preferred (E.g., Mechanical Engineering or equivalent) or a related field.
• 5-10 years of experience in Supplier Quality Engineering, preferably in the Medical Device Industry.
• Language Proficiency
• Strong ability in interpreting engineering drawings/prints.
• Proficiency in quality tools, risk analysis and statistical tools for problem-solving.
• Willingness and ability to undertake travel at the supplier end on a need basis.
• Exceptional verbal, written, presentation, and interpersonal skills.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)