Position Overview:

As the Supplier Quality Manager, you will partner with the cross-functional team to act as a champion of Supplier Quality activities throughout the product development lifecycle. You hold your work and teams to the highest quality standards and ensure all applicable compliance standards and regulations are met. This is a hands-on role requiring deep experience in supplier management, risk management, and manufacturing line bring ups and design transfer. As a Supplier Quality Manager, you will be building scalable quality systems while directly executing critical quality engineering activities across multiple programs.

Primary Duties & Responsibilities:

• Lead selection, evaluation and monitoring of suppliers and maintain the Approved Supplier List (ASL)
• Collaborate with suppliers to establish quality agreements and technical expectations
• Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity
• Create and/or maintain procedures to ensure that the organization complies with applicable regulatory standards
• Guide and support suppliers and the technical team through key activities such as process FMEAs, manufacturing flow and control plans, master validation plans, process validation (IQ/OQ/PQ), equipment qualifications
• Work with the Engineering and Operations teams to identify manufacturing test specifications, critical to quality specifications, and inspection criteria
• Oversee and manage the execution of Supplier Audits, Supplier Qualifications, Supplier Corrective Actions (SCARs), Supplier Change Assessments, Non-conformance Reports (NCRs)
• Participate in decision-making at Material Review Board (MRB) meetings
• Define KPIs and metrics for Supplier Quality and create/define systems to support the efficient collection and analysis of data for such KPIs and metrics
• Support and participate in internal and external audits, coordinating and providing documentation and evidence of compliance
• Foster a collaborative environment, champion continuous improvement initiatives and promote a quality culture across the organization

Qualifications:

• Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical, or related field).
• 10+ years of quality engineering or in medical device development from concept development to production release.
• Strong understanding of medical device regulations and standards (FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1) and experience working in a regulated environment
• Ability to travel up to 25% of the time
• Prior experience in product / manufacturing line transfers
• Hands-on experience with risk management tools (e.g. FMEA, risk analysis)
• Experience in establishing work relationships across multi-disciplinary teams and with partners in different time zones, building trust and demonstrating critical thinking
• Experience in navigating ambiguity, bringing clarity to complex situations and thriving in a fast-paced environment

Skills and Abilities:

• Proficient in working in eQMS tools with impeccable documentation skills
• Superior written and verbal communication skills to interface with cross-functional teams and regulatory bodies
• Strong analytical skills and excellent problem-solving skills
• Exceptional organizational skills and attention to detail