Senior Manager - Manufacturing QA

Posted Yesterday
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Chatsworth, GA, USA
In-Office
154K-230K Annually
Senior level
Healthtech
The Role
The Manufacturing Quality Leader ensures product quality across operations, drives collaboration, and manages quality performance in a regulated environment. Responsibilities include leadership of QA teams, ensuring compliance with global standards, and collaboration with executives to balance quality and supply chain needs.
Summary Generated by Built In

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, the ability to influence at executive level, and ownership of both quality performance and manufacturing readiness in a complex, regulated environment. 
 
Let’s talk about Responsibilities 

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. 

 
Let’s talk about Qualifications and Experience 
 
Required: 

  • 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. 

We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: 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. 

Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.

At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  A reasonable estimate of the current base range for this position is: 

$154,000 - $230 ,000  

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.

Top Skills

Iso 13485
Iso 14971
Mdsap
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The Company
HQ: San Diego, CA
5,300 Employees
Year Founded: 1989

What We Do

ResMed provides medical equipment for treating, diagnosing, and managing sleep-disordered breathing and other respiratory disorders.

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