Engineer III, QA
Engineer III, QA
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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. Youll regularly collaborate with customers to ensure our products meet worldclass 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 crossfunctional 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
- Bachelors degree in engineering or a sciencerelated 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 problemsolving 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 indepth understanding of products and processes.
- Understanding of plasticsmaterials 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.
Employment Type
Full-Time
