**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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** **Hours: 1st Shift: 7am - 3:30pm (flex)** **Overtime as needed** Join Thermo Fisher Scientific to contribute to meaningful projects like cancer research and food safety, making a tangible impact. **Location/Division Specific Information** Millersburg, Pennsylvania – Single Use Technologies Division **How will you make an impact?** The Quality Engineer II will conduct investigations, develop investigation plans, and assist in crafting corrective action plans for quality issues related to customer complaints, corrective action requests, and quality improvement requests. You will collaborate with customers regularly to ensure products meet their expectations. **What will you do?** + Collaborate with cross-functional team members to support in-process real time root cause counter measure. + Collaborate with cross-functional team members to support design for manufacturability + Collaborate with cross-functional team members to support the Customer Feedback/Complaint Handling Process & CAPA process. + Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions. + Complete Risk and Impact Assessments + Interface directly with customers and internal groups. + Develop realistic solutions to meet customer needs and solve problems. + Apply strong Root Cause / Corrective Action skills. + Drive product and process changes to improve product quality. + Perform independently and as part of a team. + Influence and negotiate with people to resolve issues. + Communicate recommendations and decisions across the organization. + Use problem-solving tools (5M, 5-whys, cause and effect, etc.). + Lead in a fast-paced technical environment, absorb and review technical information, and make technical decisions. **How will you get here?** **Education** + Minimum Required Education: HS Diploma/ GED + Preferred: Bachelor’s degree in engineering or science-related field **Experience** + 3 years of hands on experience with investigations and root cause analysis + Direct experience working with ISO 13485 or ISO 9001 and 21CFR820. + Ability to travel; domestic/foreign. + Preferred: prior experience in the medical device, biotech, or pharmaceutical industry. **Knowledge, Skills, Abilities** + Strong analytical, problem-solving, and teamwork skills. + Effective communication of complaints, risks, production, process controls, CAPA, and improvements. + Ability to analyze and process data and draw appropriate conclusions. + Knowledge of Quality Management System tools, continuous improvement methodologies, and 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. At Thermo Fisher Scientific, every one of our 140,000 outstanding minds has an unusual story to share. Join us and contribute to our exceptional mission—empowering our customers to make the world healthier, cleaner, and safer. Apply today! http://jobs.thermofisher.com 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.