Software Quality Engineer
3 days ago
Job Summary:
We are seeking a highly skilled Software Quality Engineer to join our team at LanceSoft. The successful candidate will be responsible for developing, modifying, and maintaining standards for software systems quality operating methods, processes, and procedures.
Key Responsibilities:
- Define appropriate measures to ensure software quality
- Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development strategies, risk management, and verification and validation test approaches
- Support Software New Product Development, Design Control, and Design Transfer processes, as well as responsibility for Quality deliverables during product development
- Lead risk management activities and participate on cross-functional teams to develop and maintain Product Risk Management Files
- Identify and implement software process metrics for the software product development lifecycle
- Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives
Requirements:
- University Degree and minimum of 6 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience
- Expertise in CAPA compliance & investigation techniques. Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP
- Training in Risk Management, ISO 14971:2012, hazard analysis, and Design FMEA
- Excellent written and verbal communication skills. Excellent organizational skills. Computer literacy must include proficiency with MS Office and experience with networks and applications
Working Conditions:
The contractor will work 40 hours a week and will be onsite at LAF MDT facilities, 250 *** Way, Lafayette, CO.
Interviews:
Interviews will be scheduled ASAP.
Product Line:
This person will support All Navigation product portfolios.
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