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 IS, AS, 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 ISO 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
Manual Quality Assurance Engineer
Position: Remote Manual QA Engineer. ...
Quality Assurance Engineer
Constant development of professional skills in Quality Assurance domain. Delivery of high-quality tested features/bugs. Checks fixes and closes bugs; completes the quality testing cycle. ...
Senior Quality Assurance Engineer
A dedicated Senior Quality Assurance (QA) Engineer adept at leading cross-functional QA activities, this role focuses on understanding business requirements at a functional level, identifying, writing, and testing detailed requirements with test cases. QA engineering roles, with a focus on software ...
Quality Assurance Engineer
We are seeking a Quality Assurance Engineer to join our team in Frederick, CO. Responsibilities include developing quality standards, implementing quality control systems, and leading cross-functional teams in problem-solving and implementing solid corrective actions. Minimum of 5+ years of experien...
Quality Assurance & Regulatory Affairs Manager
The Manager of Quality Assurance & Regulatory Affairs is responsible for overseeing efforts by the Quality Assurance & Regulatory Affairs department which includes developing and administering quality systems processes throughout the organization. Quality Assurance & Regulatory Affairs M...
Sr. Manager, Quality Assurance and R&D - Food Manufacturing
Be responsible for creating a strong culture of quality through process execution and enhancement, including advocating for quality throughout the product lifecycle. Proficiency in food safety quality system manufacturing processes, quality assurance principles and food manufacturing. The successful...
Home Healthcare Quality Assurance Specialist
As a QA Quality Assurance Specialist, you will play a crucial role in ensuring the quality and reliability of our home healthcare services. QA Quality Assurance Specialist. Provide recommendations and solutions to immediate quality assurance problems. Year of Quality Assurance experience. ...
Test Software Engineer
Collaborate with design and test teams to develop test equipment such as dynamometers, test stands, component testers, etc. This role will be responsible for all test equipment software including dynamometers and End-Of-Line test stands. As H3X continues to grow, additional development testing and p...
Software Quality Assurance Manager
Collaborate with cross-functional teams, including developers, product managers, and stakeholders, to define quality goals and deliverables. QA Manager with SaaS commercial experience. Are you an experienced Quality Assurance professional with a passion for leading and mentoring teams? Do you thrive...
Australian English QA Language Tester
RWS is currently seeking native-level Australian-English speakers to perform project-based, on demand QA tasks for a wide variety of translated software and Web applications. ...