Quality Specialist

JD :

• 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.

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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)