Senior Manager, Supplier Quality Assurance

New World Medical, Inc.•Rancho Cucamonga, CA

5d•$175,000 - $193,000•Onsite

About The Position

The Senior Manager, Supplier Quality Assurance is a strategic and operational leader responsible for providing direction, training, mentoring, evaluation, and development to the Supplier Quality Engineering staff. The Senior Manager, Supplier Quality Assurance leads supplier selection, supplier development, 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 Senior Manager, Supplier Quality Assurance serves as a champion for quality excellence across the organization influencing long-term planning, policy development, supplier oversight, and transformation of the supplier quality systems.

Requirements

Expert-level 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.
Proven track record of developing, communicating, and implementing, strategies for supplier selection, development, qualification, and maintenance.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with suppliers and internal cross-functional teams.
Expert-level 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.
Advanced 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.
Bachelor’s degree in Engineering, Life Sciences, or related technical discipline; advanced degree preferred.
15+ years of experience in supplier quality assurance in a medical device or regulated industry, with 7+ years of experience in a managerial role.
Certified Auditor Qualification or equivalent is required.

Nice To Haves

advanced degree preferred

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 selection, 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.
Provide leadership and oversight for supplier quality programs, including supplier risk management, performance monitoring, quality issues, and remediation activities.
Develops 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.
Develop and maintain KPIs for monitoring supplier performance, analyze and interpret trends, and identify and activate appropriate actions as necessary.
Partner with Supply Chain on planning and execution of Supplier Business Reviews.
Serve as a key advisor to executive leadership on supplier quality performance, supplier risk mitigation strategies, and supplier relationships.
Influence policy development, long-term quality planning, and organizational decision-making to support supplier relationships, business growth, and regulatory compliance.
Undertake and complete assignments as designated by Management or by the department head.