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Job Purpose:

Oversees supplier quality for the Company supplier base with a focus on supplier development through continuous improvement. Supports the selection, qualification, and management of external raw materials and finished goods suppliers. Works with manufacturers and service suppliers to ensure product / service quality meets company requirements. Interfaces with other departments (Engineering, Operations, Supply Chain) as well as with suppliers and other external parties on issues related to product quality. Effectively communicates Quality metrics through supplier scorecards and Management Review to the organization, suppliers, and Executive Management.

Responsibilities

• Primary contact to Global Procurement, Strategic Sourcing, Buyers, and Product Quality to perform supplier quality functions and activities for the purchase and control of Raw Material, Purchased Finished Goods (PFG’s), and Critical Services.
• Lead Non-Conforming Event (NCE) investigation and resolution.
• Lead Supplier Corrective Action Request (SCAR) investigation and resolution using problem-solving methods.
• Update and maintain Approved Supplier List (ASL).
• Lead supplier quality improvement/development projects.
• Lead Supplier Quality Agreement efforts including review and execution.
• Assist with the development of suppliers to provide reliable, trusting, and productive relationships.
• Primary contact to for the resolution of supplier issues, new projects, and acquisitions
• Develop strong partnerships with key stakeholders related to supplier selection, evaluation and qualification, monitoring, and development.
• Perform supplier compliance functions and activities for prospective new components.
• Perform supplier development activities with suppliers of defective materials including developing and executing Supplier Quality Plans, SCAR follow-up, and implementing six sigma and continuous improvement methods and techniques.
• Resolve ineffective supplier corrective action plans with suppliers.
• Coordinate supplier change requests.
• Develop and implement appropriate strategies to support the change request.
• Lead supplier audit activities.
• Analyze and identify trends from quality data and develop proactive measures with supplier in support of continuous improvement and supplier development.

• Travel requirements: 25% including international travel.

Job Qualifications/Requirements:

• Bachelor’s degree (B.S.) in an Engineering, Technical, or Scientific field

Minimum of 6 years of relevant experience, or advanced degree with minimum of 4 years relevant experience

• Good knowledge of risk management processes (system risk analysis, DFMEA, PFMEA)
• Prior experience working in medical device industry preferred.
• ISO 13485 Leader Auditor, preferred.
• Project Management skills preferred.
• Commitment to excellence and high standards
• Excellent written and oral communication skills preferred.
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Acute attention to detail
• Demonstrated ability to plan and organize projects.
• Ability to work independently and as a member of various teams.
• Proven ability to manage multiple projects and meet deadlines.
• Ability to develop clear, concise, and timely oral and written reports.

Accurately complete detailed forms and reports

Job Purpose:

Oversees supplier quality for the Company supplier base with a focus on supplier development through continuous improvement. Supports the selection, qualification, and management of external raw materials and finished goods suppliers. Works with manufacturers and service suppliers to ensure product / service quality meets company requirements. Interfaces with other departments (Engineering, Operations, Supply Chain) as well as with suppliers and other external parties on issues related to product quality. Effectively communicates Quality metrics through supplier scorecards and Management Review to the organization, suppliers, and Executive Management.

Responsibilities

• Primary contact to Global Procurement, Strategic Sourcing, Buyers, and Product Quality to perform supplier quality functions and activities for the purchase and control of Raw Material, Purchased Finished Goods (PFG’s), and Critical Services.
• Lead Non-Conforming Event (NCE) investigation and resolution.
• Lead Supplier Corrective Action Request (SCAR) investigation and resolution using problem-solving methods.
• Update and maintain Approved Supplier List (ASL).
• Lead supplier quality improvement/development projects.
• Lead Supplier Quality Agreement efforts including review and execution.
• Assist with the development of suppliers to provide reliable, trusting, and productive relationships.
• Primary contact to for the resolution of supplier issues, new projects, and acquisitions
• Develop strong partnerships with key stakeholders related to supplier selection, evaluation and qualification, monitoring, and development.
• Perform supplier compliance functions and activities for prospective new components.
• Perform supplier development activities with suppliers of defective materials including developing and executing Supplier Quality Plans, SCAR follow-up, and implementing six sigma and continuous improvement methods and techniques.
• Resolve ineffective supplier corrective action plans with suppliers.
• Coordinate supplier change requests.
• Develop and implement appropriate strategies to support the change request.
• Lead supplier audit activities.
• Analyze and identify trends from quality data and develop proactive measures with supplier in support of continuous improvement and supplier development.

• Travel requirements: 25% including international travel.

Job Qualifications/Requirements:

• Bachelor’s degree (B.S.) in an Engineering, Technical, or Scientific field

Minimum of 6 years of relevant experience, or advanced degree with minimum of 4 years relevant experience

• Good knowledge of risk management processes (system risk analysis, DFMEA, PFMEA)
• Prior experience working in medical device industry preferred.
• ISO 13485 Leader Auditor, preferred.
• Project Management skills preferred.
• Commitment to excellence and high standards
• Excellent written and oral communication skills preferred.
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Acute attention to detail
• Demonstrated ability to plan and organize projects.
• Ability to work independently and as a member of various teams.
• Proven ability to manage multiple projects and meet deadlines.
• Ability to develop clear, concise, and timely oral and written reports.

Accurately complete detailed forms and reports

Bachelor’s Degree