Quality Engineer II

Job Opportunity At Thermo Fisher Scientific

Work Schedule: Standard (Mon-Fri) Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Location: Detroit, MI. Relocation assistance is NOT provided. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information: Join our world-class team at Thermo Fisher Scientific Inc. in the United States, where we drive innovative manufacturing solutions in the Raw Materials division.

Discover Impactful Work: Be part of an ambitious team that ensures the production of flawless materials, contributing to life-saving products and solutions.

A Day in the Life:

• Lead qualification activities for new and existing raw materials including process management and oversight.
• Author validation protocols, reports, technical justifications and perform data analysis to support material changes and supplier qualifications.
• Evaluate raw materials to establish mitigation actions in compliance with quality standards.
• Collaborate with various groups including Procurement, Supplier Quality and R&D.
• Drive nonconformances related to raw materials. Conduct investigations and implement CAPAs following standard RCA tools.
• Write or revise standard quality control procedures and quality system documentation.

Education

Minimum Required Education: Bachelor of Science (BS) degree in engineering or science subject area.

Experience

3+ years of experience in a manufacturing Quality position in a cGMP or Life Science site. Prior qualification and/or validation background required Experience with quality inspection processes. Proven track record in implementing quality improvements. Prior Life Sciences or Pharma industry experience preferred.

Knowledge, Skills, Abilities

Strong understanding of raw material specifications. Ability to analyze data and solve problems effectively with strong attention to details. Strong interpersonal skills and ability to collaborate across various levels. Knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must. Knowledge statistical analysis tools is desirable.

Physical Requirements / Work Environment

Work requires standing for long durations, managing materials, and operating quality inspection instruments in a manufacturing setting.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, 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.

As one 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 on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access: Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process. This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.