Job Title: Quality Assurance Engineer III

Position Summary:

• Under the direction of the Manager Quality Assurance, the Quality Engineer III is process owner for site Qualification and New Product launch related results, assuring that systems and manufacturing processes are in compliance with Thermo Fisher Scientific ISO Quality Management System (QMS)to produce consistent quality product. This role is responsible for identifying, establishing, deploying new process opportunities, supporting improvement and reduced variation in our manufacturing processes.

Responsibilities:

• Lead equipment and process qualifications to improve product and process quality through direct support and monitoring of production and new product development.
• Drives the design, development, and transfer processes for new product/service projects, coordinating a project team to evaluate established requirements and measures necessary for the implementation of programs.
• Compile trend data, process capability data & other quality metrics in order to proactively propose specification or process changes.
• Approve change control documents related to the operation and improvement of Operations processes.
• Provide support in responding to customer requests for documentation, data, investigations, risk assessments and testing.
• Participate in external or internal Quality System audits to assess the compliance with the QMS, ISO standards, and internal requirements.
• Perform and support duties in accordance with quality system to support and resolve quality concerns.

Minimum Requirements/Qualifications:

• Position requires a Bachelor’s of Science Degree in Engineering, Chemistry or life sciences
• 5 years experience as a Quality Assurance Engineer in an ISO, cGMP, pharmaceutical, medical device and/or chemical environment.
• Consistent track record of hands-on problem solving expertise in a manufacturing environment. Proficiency with Microsoft Office, including data analysis & statistical methods.
• Ability to present to internal & external customers of diverse subject areas.
• Ability to travel between our two facilities in New Jersey (Bridgewater & Fair Lawn).

Professional Characteristics:

Results oriented work attitude that exhibits initiative, energy, drive, creativity, collaboration, tact, risk-based decision making and ambition. Ability to influence peers, build and maintain relationships with internal and external customers; highly functioning team member in a multi-skilled, dynamic business environment.

Leadership Skills:

Ability to be assertive and influence others and lead significant change. Strong verbal and written communication skills. Adaptable to change.

Benefits:

We offer annual incentive plan, healthcare, 401K, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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

Accessibility/Disability Access

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