Senior Manager - Manufacturing QA

ResmedChatsworth, CA
15h

About The Position

The Manufacturing Quality Leader is accountable for delivering product quality outcomes across site operations, ensuring products are consistently manufactured to specification, regulatory requirements, and global standards. This role goes beyond compliance, driving quality as a core enabler of operational performance, supply continuity, and patient safety. Through strong cross-functional collaboration and leadership, the role focuses on Manufacturing support but also embeds quality into end-to-end processes across supply chain. The position requires a strategic mindset, t he ability to influence at exec utive level, and ownership of both quality performance and manufacturing readiness in a complex, regulated environment.

Requirements

  • Bachelor’s degree in Quality or Engineering with 10 years of related experience in Supply Chain
  • Experience is setting up new sites
  • Site Quality leadership (or Management rep) experience
  • Experience leading teams of Quality managers, Engineers, Technicians and Coordinators
  • Strong knowledge and practical application of medical device quality systems and risk management principles (e.g., MDSAP , ISO 13485, ISO 14971) and global regulatory expectations as applicable to supply chain operations.
  • Demonstrated experience working across cross-functional teams to drive quality improvements within complex supply chain environments.
  • Strong communication, collaboration and stakeholder engagement skills with the ability to influence outcomes without direct authority.

Responsibilities

  • QA site(s) leadership: Act as the QA leader for products manufactured at site(s), ensuring manufacturing processes, controls, and specifications are robust, compliant, and consistently executed.
  • Own Quality Outcomes: Accountable for site quality performance, including product quality, defect rates. Ensure products are consistently manufactured to specification and regulatory requirements for global distribution.
  • Quality Leadership: Provide strategic leadership across Manufacturing Quality, driving a culture of accountability, quality ownership, and continuous improvement across sites. Lead and own the resolution of product and process quality issues.
  • Quality System & External Engagement: Own the effectiveness of the Quality Management System at site(s) and interface with certification bodies. Ensure audit readiness and timely, effective closure of all findings and corrective actions.
  • Executive Partnership: Partner with senior leadership to provide clear visibility of quality performance, risks, and trade-offs. Influence decisions to balance quality, supply, and cost without compromising patient safety or compliance.
  • Cross-Functional Accountability: Drive end-to-end quality ownership across Supply Chain including day to day operations and NPI. Embed quality into processes through Right First Time and Quality by Design principles, rather than relying on end of process inspection.
  • Team Leadership & Capability Building: Build and lead high-performing QA teams across sites. Develop leadership capability, establish succession plans, and ensure the organisation has the skills required to meet current and future quality challenges.
  • Global Alignment: Partner with global QA leadership to standardise and scale best practices, ensuring consistency and efficiency across sites.
  • Performance & Continuous Improvement: Own quality performance metrics and drive measurable improvements. Use data to proactively identify risks, eliminate defects, and improve process capability.
  • Supply Chain Quality Ownership: Accountable for quality performance across the supply chain impacting site(s), including supplier quality issues, material quality, and manufacturing transfers.
  • Manufacturing Readiness for NPI (R&D-led): Own quality readiness for new product introduction into manufacturing. Ensure manufacturing processes, controls, and risk management are in place to enable successful product launch in partnership with Product Development R&D.
  • Management Representative: Act as Management Representative where required, ensuring QMS compliance and effectiveness.
  • Industry & Regulatory Leadership: Maintain deep awareness of regulatory expectations and industry trends, translating them into proactive improvements at site and network level.

Benefits

  • comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance.
  • Employees accrue fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.
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