Thermo Fisher Scientific
Investigation QA Engineer II
Thermo Fisher Scientific, Millersburg, Pennsylvania, United States, 17061
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Investigation QA Engineer II
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Thermo Fisher Scientific 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 environment Some PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Work Schedule First Shift (Days) Hours: 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? Support in-process real-time root cause countermeasures Support design for manufacturability Support Customer Feedback/Complaint Handling & CAPA process Monitor product quality improvement and communicate with customers Complete Risk and Impact Assessments Interface with customers and internal groups Develop solutions to meet customer needs Apply root cause / corrective action skills Drive product and process improvements Work independently and in teams Negotiate and influence resolution of issues Communicate recommendations organization-wide Use problem-solving tools (5M, 5-whys, cause and effect, etc.) Lead in a fast-paced technical environment How will you get here? Education Minimum: HS Diploma/GED Preferred: Bachelor’s in engineering or science-related field Experience At least 3 years of investigation and root cause analysis experience Experience with ISO 13485, ISO 9001, and 21CFR820 Ability to travel domestically and internationally Preferred: experience in medical device, biotech, or pharmaceutical industries Knowledge, Skills, Abilities Strong analytical and teamwork skills Effective communication skills Data analysis and conclusion drawing skills Knowledge of Quality Management Systems and continuous improvement tools Understanding of plastics materials and manufacturing Prioritization skills Interpersonal, organizational, and influencing skills Proficiency in Microsoft Office and MiniTab ASQ certification preferred At Thermo Fisher Scientific, every one of our 140,000 outstanding minds has an unusual story to share. Join us and contribute to our mission—empowering our customers to make the world healthier, cleaner, and safer. Apply today!
http://jobs.thermofisher.com
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Investigation QA Engineer II
role at
Thermo Fisher Scientific 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 environment Some PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Work Schedule First Shift (Days) Hours: 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? Support in-process real-time root cause countermeasures Support design for manufacturability Support Customer Feedback/Complaint Handling & CAPA process Monitor product quality improvement and communicate with customers Complete Risk and Impact Assessments Interface with customers and internal groups Develop solutions to meet customer needs Apply root cause / corrective action skills Drive product and process improvements Work independently and in teams Negotiate and influence resolution of issues Communicate recommendations organization-wide Use problem-solving tools (5M, 5-whys, cause and effect, etc.) Lead in a fast-paced technical environment How will you get here? Education Minimum: HS Diploma/GED Preferred: Bachelor’s in engineering or science-related field Experience At least 3 years of investigation and root cause analysis experience Experience with ISO 13485, ISO 9001, and 21CFR820 Ability to travel domestically and internationally Preferred: experience in medical device, biotech, or pharmaceutical industries Knowledge, Skills, Abilities Strong analytical and teamwork skills Effective communication skills Data analysis and conclusion drawing skills Knowledge of Quality Management Systems and continuous improvement tools Understanding of plastics materials and manufacturing Prioritization skills Interpersonal, organizational, and influencing skills Proficiency in Microsoft Office and MiniTab ASQ certification preferred At Thermo Fisher Scientific, every one of our 140,000 outstanding minds has an unusual story to share. Join us and contribute to our mission—empowering our customers to make the world healthier, cleaner, and safer. Apply today!
http://jobs.thermofisher.com
#J-18808-Ljbffr