Quality Engineer III, CAPA

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! Join 100,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges. This includes protecting the environment, making sure our food is safe, and helping find cures for cancer.

As a CAPA Quality Engineer, you will provide support to ensure the site meets all the requirements for an effective CAPA program governed by ISO 13485 and 21CFR820. You can help make an impact by providing QA support to enable the site to perform effective investigational work, identify true root cause and generate robust corrective and preventative actions. This is a very hands-on role and works collaboratively with other departments.

What will you do?

• Primary duties will include working with cross functional department for investigations, root cause analysis, and corrections/corrective actions to ensure proper documentation and closure, provide trending and issues as appropriate
• Analyze and trend all types of data (CAPA, problem records, complaints, on market surveillance) to identify deficient areas and initiate quality improvement projects
• Participate in third party audits, external customers and Agency inspections as needed and support internal activities concerning any identified nonconformities
• Write, review, and approve CAPAs to ensure timely resolution of quality problems
• Promote and implement improvements and compliance with site Quality Management System requirements
• Participate in departmental projects and improvement initiatives through the site’s PPI Program and partner with other groups to continuously improve
• Prepare clearly written business communications
• Write, review, analyze and revise written relevant Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Site, Regulatory Requirements
• Perform other duties to support the quality department as assigned.

How will you get here?

Education

• Bachelor’s degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences

Experience

• Experience working in ISO 13485 and/or GMP environment
• 2+ years of work experience in Quality Assurance/Systems/Engineer role
• Strong computer skills (Office, Project, Teams, Visio, Word, Excel); experience with Agile, and TrackWise, and E1 a plus.
• Experience with Quality tools, methodologies, investigations, including root cause analysis
• Experience working & collaborating with internal and external customers

Knowledge, Skills, Abilities

• Must be self-motivated, organized, detail oriented, and have ability to complete projects and assignment and be comfortable to work under minimal supervision, independently, and work with a diverse team
• Strong analytical and problem-solving skills with attention to details and the ability to find creative solutions that meet regulatory and business requirements
• Solid organizational skills with ability to balance complex and routine work activities and competing priorities and the ability to manage time effectively and prioritize work
• Highly energetic, positive demeanor, works well under stress
• Excellent communication and social skills with the ability to interact with all levels of the organization both orally and in writing; consistent track record of working cross functionally
• Ability to work in teams and independently to obtain results as required; including ability to resolve quality related issues in a timely and effective manner
• Results oriented, make sound business decisions and multi-tasking skills are a must
• Must demonstrate strong organizational skills and attention to details
• Collaborate and communicate both vertically and horizontally in a way that commands both personal respect and mission acceptance