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Stryker

Manager, Quality Assurance

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What they do

A Quality Assurance Manager focuses on prevention of mistakes and defects in manufacturing products. Develops procedures to ensure that quality standards are maintained. Manages all steps related to quality assurance as part of the quality management strategy of a company. May involve leadership of a team of quality assurance supervisors, specialists, and other associated staff members.

$101,398 / year median in Tennessee

+3% projected growth

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Job Description

Manager, Quality Assurance Stryker - 3.8 Franklin, TN Job Details Full-time $102,600 - $171,000 a year 7 hours ago Benefits Health savings account AD&D insurance Employee stock purchase plan Paid holidays Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Vision insurance Prescription drug insurance Qualifications Regulatory inspections Defect resolution root cause analysis Quality control statistical data analysis Preventive action implementation Statistical Process Control Production deviation management Corrective and preventive actions (CAPA) Change management Quality risk management Medical device manufacturing facility experience Regulatory readiness in healthcare Regulatory/legal compliance standards in production Biomedical regulatory compliance Operational excellence initiatives Quality audits Managing product quality assurance teams Quality improvement programs in engineering Healthcare compliance Product quality failure FDA regulations Audit support Failure analysis Full Job Description Why join Stryker? Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific. Job description We are excited to be named one of the World's Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:

US Stryker employee benefits. The Manager Quality Operations will work within the Quality Operations structure, in a management capacity, has responsibility for quality related activities which include, but not limited to the following: What You Will Do Lead the Quality Assurance team, providing technical guidance and quality oversight across manufacturing and operations, supports functions to drive continuous improvement and compliance. Partner with site leadership to ensure products consistently meet customer expectations, regulatory requirements, and applicable quality standards. Develop, coach, and retain a high-performing team while fostering a culture of inclusion, accountability, collaboration, and employee engagement. Drive quality system compliance by partnering with functional leaders to establish, communicate, and maintain quality standards, requirements, and responsibilities. Lead site readiness activities and support internal, corporate, notified body, FDA, and other regulatory audits and inspections. Oversee the management of nonconforming products, product and process deviations, risk assessments, corrective actions, and preventive actions to ensure effective resolution and compliance. Monitor and improve Quality performance indicators, including NCR, CAPA, compliance, and operational quality metrics, and implement corrective actions for adverse trends. Support the development and execution of local and global Quality Operations strategies that improve product quality, operational efficiency, risk management, and regulatory compliance. What You Need Bachelor's degree in Engineering, Science, or a related technical discipline. Minimum 6 years of experience in a medical device, pharmaceutical, biomedical, automotive, or other regulated manufacturing environment. Experience leading quality assurance or quality operations activities within a regulated industry. Experience supporting FDA inspections, notified body audits, and other regulatory audits. Knowledge of global quality regulations, standards, and quality management systems. Working knowledge of quality tools including Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, and Six Sigma methodologies. Experience managing nonconformances, CAPAs, quality investigations, and risk assessments. Experience implementing quality improvement initiatives and driving organizational change. Preferred Qualifications Master's degree in Business Management, Engineering, Science, or an MBA. Experience leading and developing high-performing quality teams in a manufacturing environment. Experience establishing quality strategies and performance improvement programs across multiple sites or business units. Black Belt, Green Belt, or equivalent Lean/Six Sigma certification. Experience supporting global quality systems, regulatory compliance initiatives, and continuous improvement programs. Experience influencing cross-functional stakeholders and driving quality culture initiatives.
United States of America Pay Ranges:
USN :
$102,600 - $171,000 USD Annual View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include:
Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include:
Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.