JOB SUMMARY:

The Manager, Supplier Quality Assurance is responsible for providing direction, leadership, training, mentoring, evaluation, and development to the Supplier Quality Engineering staff. The Manager, Supplier Quality Assurance, will provide resource allocation and technical support for supplier qualifications, supplier maintenance, supplier audits, supplier corrective actions, supplier change notifications, supplier Production Part Approval Process, CAPAs, NCRs, Quality Agreements, and Change Requests. The Manager, Supplier Quality Assurance leads or supports the execution of initiatives and projects to enhance quality systems, process and product performance, and analyzes data to present for monitoring and other optimization activities. The Manager, Supplier Quality Assurance will ensure compliance with regulations and standards and assist with internal and external audits.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Perform all work in compliance with New World Medical’s company policy and Quality System, as well as applicable regulations and standards.
• Develop and maintain an effective workforce of supplier quality engineers to facilitate accomplishment of quality goals and objectives.
• Evaluate and coordinate resource allocation for supplier quality engineering activities.
• Provide technical support and guidance for supplier qualifications, supplier evaluations, supplier audits, supplier corrective actions, supplier change notifications, supplier Production Part Approval Process, CAPAs, NCRs, Quality Agreements, and Change Requests.
• Schedules, manages, and conducts audits for existing and potential new suppliers to assess compliance with applicable Standards, Regulations, and New World Medical Requirements.
• Drives continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams including NWM and suppliers.
• Works with suppliers and New World Medical’s R&D, Sustaining, and Production Department to establish, maintain, and assess associated risks of their controlled manufacturing processes.
• Leads the qualification and maintenance process for suppliers, including initial and routine supplier evaluation, audits, and establishment of quality agreements, as required.
• Builds and maintains relationships with suppliers to establish and verify/audit control methods suitable to the nature of the parts they supply and ensure clear communication of New World requirements to all levels of manufacturing.
• Works with suppliers to establish a structured approach for consistency and adherence to quality procedures and requirements.
• Works with suppliers on establishing robust validated processes including measurement methodologies.
• Develop and maintain KPIs for monitoring supplier performance, analyze and interpret trends, and identify and activate appropriate actions as necessary.
• Undertake and complete assignments as designated by Management or by the department head.

KNOWLEDGE, SKILLS AND ABILITIES:

• Excellent understanding of regulations applicable to Medical Devices (e.g., ISO 13485, QMSR, etc.).
• Proven track record of leading supplier quality engineering teams and driving process improvements.
• Demonstrated ability to develop, communicate, and implement, strategies for the qualification and maintenance of suppliers.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with suppliers and internal cross-functional teams.
• Technical knowledge of Supplier Management, Supplier Audits, Production Part Approval Process, Process Validation, Quality Agreements, and Measurement System Analysis.
• Ability to communicate in writing and orally with auditors, suppliers, supervisors, and co-workers.
• Demonstrate strong organizing, planning, and prioritizing abilities.
• Solid problem analysis and decision-making ability and leadership skills.
• Must be able to adapt to change in the workplace and demonstrate flexibility with new ideas.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline; advanced degree preferred.
• 10+ years of experience in supplier quality assurance in a medical device or regulated industry, with 3+ years of experience in a managerial role.
• Certified Auditor Qualification or equivalent is required.

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time.
• Occasionally move about inside the office and travel to and from office buildings to access file cabinets, employee offices, office machinery, etc. This may include, but is not limited to, bending and walking.
• Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
• Ability to listen and speak with employees and suppliers. Must be able to exchange accurate information in these situations.
• View and type on computer screens for long periods of time.
• Expected travel for this position is approximately 25%-40% both domestic and abroad.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.