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We are seeking a Sr. Quality Assurance Manager to lead our Quality Operations and Quality Engineering teams or our medial device company, ensuring exceptional product quality and compliance with regulatory standards. This role requires strategic project management skills to handle multiple projects with competing priorities. The manager will be responsible for developing Quality Control Plans, utilizing data to enhance Quality Control and CAPA operations, validating test methods, and managing environmental monitoring in production areas. Other key responsibilities include overseeing sterilization validation activities, leading root cause analysis investigations for effective CAPA resolution, qualifying and monitoring suppliers, deploying risk mitigations to ensure product safety, and participating in regulatory inspections and customer audits. Continuous innovation and improvement of testing methods and processes are crucial.
Hard Skills
CAPA
Supplier Management
Continuous Improvement
Quality Control Plans Development
Test Methods Validation
Data Analysis
SOP Writing/Revising
Document Review and Approval
Environmental Monitoring
Sterilization Validation
Root Cause Analysis
Regulatory Inspections Participation
Soft Skills
Conflict Management
Competing Priorities Management
People Development
Job Type
This is a permanent position.
Work Site
This is a fully on-site position in Allen, Texas.
Work Environment
The Sr. Quality Assurance Manager will oversee a team consisting of 1 Quality Engineer, 1 Quality Supervisor, and 2 Quality Managers, along with their respective teams (4 members each), focusing on electronics and disposables.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Are Embedded Into Our Culture Through
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Business Consulting and Services
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