Quality Engineer III
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Job Location:
Monthly Salary:
Posted on:
04-09-2025
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
This role calls for a hands-on professional with a robust background in quality risk assessment and CAPA investigations. The ideal candidate will have a strong grasp of ISO and FDA quality frameworks and the ability to lead investigations and continuous improvement initiatives across both development and production environments.
What will you do
- Lead cross-functional team members supporting 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 Risk and Impact Assessments.
- Interface directly with customers and internal groups.
- Develop realistic solutions to meet customer needs and solve problems.
- Drive product and process changes to improve product quality.
- Provide support to QE team members.
- Communicate recommendations and decisions across the organization.
- Apply problem-solving tools (8D 5-whys cause and effect etc.).
- Demonstrate strong root cause/corrective action skills.
How will you get here
Education:
- Bachelors degree in an Engineering or science related field required
Experience:
- 5 years of experience in an Engineering Quality or Regulatory capacity required (preferably within the medical device biotech or pharmaceutical sector)
- Direct experience working with ISO 13485 ISO 9001 and 21CFR820 required.
Knowledge Skills and Abilities:
- Strong analytical problem-solving and teamwork skills.
- Proficient with Microsoft tools (Word Excel PowerPoint Visio Teams) and MiniTab.
- Excellent written and verbal communication skills.
- Ability to analyze and process data and draw appropriate conclusions.
- Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.
- Understanding of plastics materials properties manufacturing processes and product assembly.
- Experience prioritizing conflicting demands.
- Excellent interpersonal organizational and influencing skills.
- ASQ certification is desired.
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
