Investigation QA Engineer II
Investigation QA Engineer II
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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 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: Bachelors 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 140000 outstanding minds has an unusual story to share. Join us and contribute to our exceptional missionempowering our customers to make the world healthier cleaner and safer. Apply today!
Employment Type
Full-Time
