Quality Engineer III
Quality Engineer III
Posted on :
04-09-2025
Employer Active
1 Vacancy
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Job Description
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.
Employment Type
Full-Time
Key Skills
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