Quality Assurance Engineer
Job Description
The Role:
We are seeking a Quality Assurance Engineer to join our team in Frederick, CO. In this role, you will collaborate with the team to ensure the quality of our processes and outputs. Responsibilities include developing quality standards, implementing quality control systems, and leading cross-functional teams in problem-solving and implementing solid corrective actions. A successful candidate should have excellent problem-solving skills and be meticulous in ensuring our processes and products meet customer requirements and regulatory standards.
Responsibilities:
- Develop and implement quality standards and systems
- Monitor and analyze quality performance with working knowledge of statistical controls
- Ensure compliance with various regulatory requirements, such as IS013485, AS9100, ITAR, 21 CFR Part 11, REACH/RoHS, and CMRT
- Utilize quality tools like 5why, fishbone, APQP, PPAP, PFMEA, SPC, and MSA
- Collaborate with operations to develop and implement process controls and improvements
- Ensure workflows, processes, and products meet customer and regulatory requirements
- Investigate and troubleshoot product or production issues
- Drive corrective action efforts, solutions, and continual improvements
- Handle customer quality issues and manage scorecard feedback
- Conduct customer audits and internal audits, assist with external audits
- Manage supplier issues, including issuing Supplier Corrective Actions
- Represent quality at MRB and Product Launches for NPI
- Maintain document control
- Manage supplier relationships and regulatory/certification updates
Requirements:
- Minimum of 5+ years of experience in Quality Engineering within the medical manufacturing industry
- Bachelor's degree in engineering or a technical field
- 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
