Software Quality Assurance Engineer
4 days ago
We are seeking a highly skilled Software Quality Assurance Engineer to join our team at LanceSoft. The successful candidate will be responsible for ensuring the quality of our software systems and processes, working closely with cross-functional teams to develop and maintain quality standards and procedures.
Key Responsibilities:
- Develop and maintain software quality standards and procedures
- Participate in new product development lifecycle, engaging with cross-functional partners on design concepts, risk management, and verification and validation test approaches
- Support Software New Product Development, Design Control, and Design Transfer processes
- 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, working independently to determine and develop imaginative, thorough, and practicable solutions
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 and investigation techniques, auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, ISO 14971:2012, CMDR, 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, and computer literacy including proficiency with MS Office and experience with networks and applications
What We Offer:
- A dynamic and collaborative work environment
- Opportunities for professional growth and development
- A competitive salary and benefits package
How to Apply:
If you are a motivated and experienced Software Quality Assurance Engineer looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information]. We look forward to hearing from you
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