What are the responsibilities and job description for the Sr Supplier Quality Engineer position at The Ascent Group, LLC?
MUST HAVE ISO 13485 EXP
MUST HAVE MED DEVICE CLASS II EXP
MUST HAVE INTERNAL/EXTERNAL AUDIT EXP & FDA EXP
Participate on the core team for development projects and transfer to manufacturing with internal or external manufacturing facilities.
Utilize risk-based approach in the classification and management of suppliers.
Manage supplier issues arising at incoming inspection or on manufacturing floor.
Resolution of quality issues including supplier non-conformances, corrective action requests, and CAPA.
Lead the qualification of new suppliers, including supplier selection and approval.
Responsible for coordinating initial component quality requirements, including first article inspection, process qualification, and assisting in supplier validation activities such as writing/approving protocols.
Provide insight regarding supplier capabilities for new and existing products, in collaboration with manufacturing, engineering, R&D, and marketing.
Conduct external supplier audits to ensure compliance. Independently manage resolution of quality issues observed during audit process to raise level of supplier performance.
Requirements
Working experience in a medical device or life sciences industry.
Strong written/verbal communication skills and demonstrated use of quality tools/methodologies.
Working knowledgeable of design control requirements and manufacturing design transfer process
Working knowledge of FDA/QSR, ISO/EU MDR standards, process validation, product design control, CAPA/SCAR, and FMEA methodologies.
Proficient with Microsoft Office applications.
Certified Internal Auditor and/or experience performing Internal Audits strongly preferred.
Educational Requirements
Current ASQ and/or six sigma certifications preferred.
Bachelor of Science degree in a technical discipline
MUST HAVE MED DEVICE CLASS II EXP
MUST HAVE INTERNAL/EXTERNAL AUDIT EXP & FDA EXP
Participate on the core team for development projects and transfer to manufacturing with internal or external manufacturing facilities.
Utilize risk-based approach in the classification and management of suppliers.
Manage supplier issues arising at incoming inspection or on manufacturing floor.
Resolution of quality issues including supplier non-conformances, corrective action requests, and CAPA.
Lead the qualification of new suppliers, including supplier selection and approval.
Responsible for coordinating initial component quality requirements, including first article inspection, process qualification, and assisting in supplier validation activities such as writing/approving protocols.
Provide insight regarding supplier capabilities for new and existing products, in collaboration with manufacturing, engineering, R&D, and marketing.
Conduct external supplier audits to ensure compliance. Independently manage resolution of quality issues observed during audit process to raise level of supplier performance.
Requirements
Working experience in a medical device or life sciences industry.
Strong written/verbal communication skills and demonstrated use of quality tools/methodologies.
Working knowledgeable of design control requirements and manufacturing design transfer process
Working knowledge of FDA/QSR, ISO/EU MDR standards, process validation, product design control, CAPA/SCAR, and FMEA methodologies.
Proficient with Microsoft Office applications.
Certified Internal Auditor and/or experience performing Internal Audits strongly preferred.
Educational Requirements
Current ASQ and/or six sigma certifications preferred.
Bachelor of Science degree in a technical discipline
