Quality Engineer
Job Description
The Role:
Our QE will work with the team to monitor and improve the quality of our processes and outputs. You will be responsible for designing quality standards, developing quality control systems, and leading cross-functional teams in problem-solving, resulting in innovative, solid corrective actions.
A successful quality engineer should be an exemplary problem solver and diligent at ensuring our processes and products consistently meet our customer requirements and all regulatory standards.
Quality Engineer Responsibilities:
· Developing and implementing quality standards and systems
Monitoring and analyzing quality performance and have working knowledge of statistical controls.
· Working knowledge of Regulatory Requirements: IS013485, AS9100, ITAR, 21 CFR Part 11, REACH/RoHS, CMRT,
· Working knowledge of Quality Tools: 5why, fishbone, APQP, PPAP, PFMEA, SPC, MSA,
· Collaborating with operations to develop and implement controls and improvements.
· Ensure that workflows, processes, and products comply with customer and regulatory requirements.
· Lead the investigation and troubleshooting of product or production issues.
· Drive corrective action efforts, solutions, and continual improvements.
· Customer contact for quality issues and owner of scorecard feedback on quality.
· Conducting customer audits and internal audits and assisting with external audits.
· Responsible for dealing with supplier issues, including issuing Supplier Corrective Actions and follow-through.
· Quality Representative at MRB and Product Launches for NPI.
· Responsible for maintaining document control.
· Responsible for supplier management, including Approved Vendor List and managing regulatory and certification updates.
Quality Engineer Requirements:
· Minimum of 5+ years of experience in Quality Engineering in the medical manufacturing industry.
· Minimum of bachelor’s degree in engineering (or technical degree).
· Active ISO13485 Lead auditor certificate.
· Strong GD&T working knowledge.
· Proficient in Microsoft Word, Excel, and PowerPoint
· Strong communication and interpersonal skills
· Strong analytical and problem-solving skills
· Self-driven, curious, and driven!
