Engineer I, QA

Work Schedule
First Shift (Days)

Environmental Conditions
Office

Job Description

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