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Quality Engineer
2 months ago
Quality Engineer - Medical Devices
The Role: Our client's Quality Engineer (QE) will collaborate with the team to monitor and enhance the quality of processes and outputs. You will be tasked with designing quality standards, developing quality control systems, and leading cross-functional teams in problem-solving to create innovative and robust corrective actions.
A successful candidate should be an exemplary problem solver and diligent in ensuring our processes and products consistently meet customer requirements and regulatory standards.
Responsibilities:
- Developing and implementing quality standards and systems.
- Monitoring and analyzing quality performance with a working knowledge of statistical controls.
- Familiarity with Regulatory Requirements: ISO13485, AS9100, ITAR, 21 CFR Part 11, REACH/RoHS, CMRT.
- Proficiency in Quality Tools: 5why, fishbone, APQP, PPAP, PFMEA, SPC, MSA.
- Collaborating with operations to develop and implement controls and improvements.
- Ensuring workflows, processes, and products comply with customer and regulatory requirements.
- Leading the investigation and troubleshooting of product or production issues.
- Driving corrective action efforts, solutions, and continual improvements.
- Acting as the customer contact for quality issues and owner of scorecard feedback on quality.
- Conducting customer audits, internal audits, and assisting with external audits.
- Managing supplier issues, including issuing Supplier Corrective Actions and follow-through.
- Serving as the Quality Representative at MRB and Product Launches for NPI.
- Maintaining document control.
- Overseeing supplier management, including the Approved Vendor List and managing regulatory and certification updates.
Requirements:
- Minimum of 5+ years of experience in Quality Engineering in the medical manufacturing industry, with experience in Class 2 or higher devices.
- Bachelor's degree in engineering (or a technical degree).
- Active ISO13485 Lead Auditor certificate.
- Strong working knowledge of GD&T.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving skills.
- Self-driven, curious, and motivated
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