When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like enabling our customers to make the world healthier, cleaner, and safer. The work we do has a real-world impact, and will provide experiences needed to achieve your career goals!

Position: Quality Assurance Supervisor (2nd Shift)

Hours: 2nd Shift, Monday - Friday 2PM - 10:30PM

Location/Division Specific Information:

Location: Frederick, MD

Division: Genetic Sciences Division

How will you make an impact?

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?

Education, Experience:

• Bachelor’s Degree or higher is required; preferably in technical/scientific field.
• Minimum of 3 years Quality Systems experience in a healthcare supervised industry (Medical Device preferred) is required.
• A broad-based technical knowledge and skills in Quality Systems is required.
• Previous team lead/supervisory experience preferred.

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 empower and influence others.
• Excellent verbal and written skills to optimally communicate to a variety of internal and external audiences, while counseling, negotiating and formally communicating 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, growing 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. For more information, please visit www.thermofisher.com.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.