The Senior Engineer, Quality Engineering (Manufacturing Quality) is responsible for leading QC operations while providing Quality Engineering support for manufacturing. The role ensures product quality, regulatory compliance, effective quality systems, and continuous improvement through leadership of quality inspections, investigations, NPI activities, manufacturing quality initiatives, and cross-functional collaboration. (On-site)
Let's talk about Responsibilities- Lead and manage Quality Control (QC) teams to ensure inspection activities support production schedules, product quality, and business objectives.
- Support Factory Focus Teams in achieving Quality, Delivery, and Cost (QDC) KPIs.
- Provide day-to-day leadership, coaching, mentoring, and development of personnel.
- Drive quality oversight for manufacturing operations, including inspection, nonconforming material disposition, root cause investigations, CAPAs, and continuous improvement initiatives.
- Lead and support New Product Introduction (NPI) activities, ensuring quality deliverables, risk management, and successful transfer into manufacturing.
- Partner and work collaborative with Manufacturing, Engineering, Supply Chain, Supplier Quality, and Operations teams to resolve quality issues and improve process performance.
- Monitor and analyze quality metrics and inspection data to identify trends, improve efficiency, and drive corrective and preventive actions.
- Ensure compliance with ResMed Quality Management System (QMS), FDA Quality System Regulations, GMP, ISO standards, and applicable regulatory requirements.
- Maintain and improve manufacturing quality systems, inspection processes, risk assessments, validation activities, and quality plans.
- Support internal, external audits, and ensure timely closure of audit observations.
- Serve as a quality representative for strategic operational initiatives including site expansions, process changes, equipment transfers, and business integration activities.
- Promote a culture of quality, accountability, compliance, and continuous improvement across manufacturing and quality functions.
- Networks with contacts outside own area of expertise.
- Works independently, with guidance in only the most complex situations.
- Frequently leads sub-functional teams or projects and train and mentor junior team members.
- Serves as a best practice resource within own area of work.
- Schedule flexibility as needed
Let's talk about Qualifications and ExperienceRequired:- Bachelor's degree in Engineering, Science, or related field.
- 5+ years of experience in Manufacturing Quality, Quality Engineering, or Quality Control within a regulated manufacturing environment.
- Experience with Quality Systems, risk management, process validation, CAPA, nonconformance management, and root cause investigations.
- Demonstrated leadership experience managing, mentoring, or supervising QC and/or quality personnel.
- Strong collaboration, communication, stakeholder management, and problem-solving skills.
- Working knowledge of FDA QSR, GMP, ISO 13485, MDSAP and applicable regulatory requirements.
Preferred:- Medical device industry experience.
- ASQ certified
- Knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
- Experience utilizing data analytics AI-enabled tools to improve quality performance and operational decision-making.
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:
$122,000 - $184,000. Annual bonus is 5%.
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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.
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