Engineer III, QA

Work Schedule
First Shift (Days)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

At Thermo Fisher Scientific, you will lead risk assessments, develop investigational plans, and develop corrective action plans for quality issues. You'll regularly collaborate with customers to ensure our products meet world-class expectations. This role offers a chance to define a significant impact by improving our product quality and supporting crucial processes!

What will you do?

• Collaborate with cross-functional team members to support the Customer Feedback/Complaint Handling Process and CAPA process.
• Monitor product quality improvement to ensure execution of actions, including any resulting customer communications/interactions.
• Complete and lead Risk and Impact Assessments.
• Interface directly with customers and internal groups.
• Develop realistic solutions to meet customer needs and solve problems.
• Drive product and processing changes to improve product quality.
• Communicate recommendations and implement decisions across the organization.

How will you get here?

Education

• Bachelor's degree in engineering or a science-related field, or equivalent experience in Quality or Operations roles within the biotech or pharmaceutical industry.

Experience

• 5 years' experience in the medical device, biotech, or pharmaceutical industry.
• Direct experience of working with ISO 13485 or ISO 9001 and 21CFR820.
• Ability to travel; domestic/foreign.

Knowledge, Skills, Abilities

• Strong analytical, problem-solving, and teamwork skills are required.
• Experience effectively communicating complaints, risks, production, process controls, Corrective and Preventive Actions (CAPA), and improvements.
• Ability to analyze and process data and draw the appropriate conclusions.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, and an in-depth understanding of products and processes.
• Understanding of plastics-materials, properties, manufacturing processes, and product assembly.
• Experience prioritizing conflicting demands.
• Excellent interpersonal, organizational, and influencing skills.
• Proficient with Microsoft tools: Word, Excel, PowerPoint, Visio, Teams; MiniTab.
• ASQ certification is desired.