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ResMed · 3 days ago
Quality Engineer (QC Team Lead)
Lithia Springs, GA
Full-time
Hybrid
Senior Level
5+ years exp
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Responsibilities
Collaborate with teams to develop and maintain quality standards, procedures, and documentation in compliance with regulatory requirements.
Perform data and trend analyses to support organizational needs, non-conformance management, and continuous improvement activities.
Lead/Support investigations into quality issues, conduct root cause analysis, and implement corrective and preventive actions.
Assess and mitigate quality risks throughout the product lifecycle, including supplier quality management and incoming inspection processes.
Direct supervision of QC team members to oversee Quality Control operations and ensure adherence to protocols and standards.
Supervise QC technicians and inspectors, provide guidance, training, and support team members' development.
Drive a culture of continuous improvement, promote best practices, and collaborate with cross-functional teams to enhance efficiency.
Ensure compliance with relevant regulatory requirements, standards, and guidelines such as ISO 13485 and FDA regulations.
Build collaborative relationships with cross-functional teams to support product development processes and ensure adherence to Quality and GMP requirements.
Analyze QC data and metrics to monitor performance, identify trends, and implement corrective actions.
Qualification
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Required
Bachelor’s degree in Engineering or a related field
5 years experience in a regulated volume manufacturing industry
Strong understanding of quality control principles and methodologies, including statistical process control (SPC) and quality management systems (QMS)
Knowledge of relevant regulatory requirements and standards, such as ISO 13485 and FDA regulations
Excellent analytical and problem-solving skills, with the ability to conduct root cause analysis and implement effective solutions
Strong relationship management and communication skills, with the ability to effectively communicate complex technical information to cross-functional teams
Preferred
Advanced degree preferred (Masters in Engineering, Biomedical Engineering, MBA etc.)
Experience in high volume manufacturing & distribution within medical device or healthcare industry
Proven experience in supervising and leading teams
Benefits
Comprehensive medical
Vision
Dental
Life insurance
AD&D
Short-term disability insurance
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)
Tuition assistance
Company
ResMed
ResMed provides medical devices to treat and manage sleep apnea and pulmonary diseases.
5,001-10,000 employees
H1B Sponsorship
ResMed has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (6)
2022 (11)
2021 (18)
2020 (24)
Funding
Current Stage
Late StageLeadership Team
Michael "Mick" Farrell
Chief Executive Officer
Sanjay Kumar
Chief Technology Officer - ResMed SaaS
Recent News
2024-04-28
Yahoo Finance
2024-04-26
Company data provided by crunchbase
