Engineer I, QA

Thermo Fisher Scientific•Marietta, OH

1d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment. REQUIREMENTS: • Bachelor's Degree required, no prior experience required. Experience in pharmaceutical, medical device or regulated industry preferred • Preferred Fields of Study: Mechanical or Industrial Engineering, or related scientific/technical field • Strong analytical and problem-solving skills for quality investigations and root cause analysis • Experience with continuous improvement methodologies (Lean, Six Sigma) preferred • Additional certifications in Quality Systems or GMP preferred • Strong knowledge of cGMP, ISO standards (13485 or 9001), and international regulatory requirements • Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA • Proficiency in quality management software systems (TrackWise, SAP, etc.) • Demonstrated ability to perform detailed documentation review and quality assessments • Excellent written and verbal communication skills • Ability to work independently and collaborate effectively with cross-functional teams • Experience conducting internal quality audits and supporting external regulatory audits • Proficient computer skills including Microsoft Office applications • Strong attention to detail and commitment to accuracy • Ability to prioritize and adapt in a changing environment • May require up to 10% travel • Must be able to work in controlled environments wearing required PPE Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $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 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Requirements

Bachelor's Degree required, no prior experience required. Experience in pharmaceutical, medical device or regulated industry preferred
Preferred Fields of Study: Mechanical or Industrial Engineering, or related scientific/technical field
Strong analytical and problem-solving skills for quality investigations and root cause analysis
Experience with continuous improvement methodologies (Lean, Six Sigma) preferred
Additional certifications in Quality Systems or GMP preferred
Strong knowledge of cGMP, ISO standards (13485 or 9001), and international regulatory requirements
Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
Proficiency in quality management software systems (TrackWise, SAP, etc.)
Demonstrated ability to perform detailed documentation review and quality assessments
Excellent written and verbal communication skills
Ability to work independently and collaborate effectively with cross-functional teams
Experience conducting internal quality audits and supporting external regulatory audits
Proficient computer skills including Microsoft Office applications
Strong attention to detail and commitment to accuracy
Ability to prioritize and adapt in a changing environment
May require up to 10% travel
Must be able to work in controlled environments wearing required PPE