We have an exciting opening for a Quality Assurance Supervisor! This hands-on role will provide oversight and leadership for the Quality Assurance second shift direct manufacturing support team.
What will you do?
Supervise a team of 2-3 quality personnel, supporting product review and release for manufacturing second shift operations.
Supervise and collaborate cross functionally and be able to influence appropriate outcomes
Review Device History Records (DHR’s) and associated documents to ensure that all documents and specifications are met.
Identify non-conformances and trend / report device history batch issues.
Perform physical inspection of product to ensure compliance to packaging and labeling specifications
Ensures activities and items are in compliance with both company quality assurance standards and applicable quality system regulations.
Resolve incomplete or unexplained issues found during the batch review with manufacturing.
Facilitate CAPA, complaint and non-conformance investigations as it relates to second shift operations.
Management of organizational performance and succession planning through training and development
Maintain a culture of high employee engagement, collaboration and flexibility.
How will you get there?
Minimum Requirements :
Position may require Covid-19 vaccination, including a booster and / or routine testing, per client discretion. As a requirement to be onsite at Thermo Fisher Scientific this position requires vaccination status disclosure upon employment.
Education, Experience :
Bachelor’s Degree or higher is required; preferably in technical / scientific field
Minimum of 3-5 years Quality Systems experience in a healthcare regulated industry (Medical Device preferred) is required.
A broad-based technical knowledge and skills in Quality Systems is required.
Knowledge, Skills, Abilities
Experience within an FDA QSR and ISO environment is highly preferred.
Experience in communicating with FDA and other internal external auditors is preferred.
Knowledge of the US FDA Quality System Regulations and ISO 13485.
Strong collaboration and influencing skills with team building and development capabilities.
Excellent relationship building and persuasion skills with the ability to motivate and influence others
Excellent verbal and written skills to successfully communicate to a variety of internal and external audiences, while counseling, negotiating and formally presenting views and / or technical criteria clear and assertive communication style
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE : TMO) is the world leader in serving science, with annual revenue of approximately $40 billion .
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.