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Senior Quality Assurance Engineer
2 months ago
We are seeking a dedicated and experienced Quality Assurance Engineer to join our team at Elyon International, Inc. This role is pivotal in ensuring that our products meet the highest standards of quality and compliance throughout their lifecycle.
Key Responsibilities- Quality Assurance: Develop and implement comprehensive quality, reliability, and Post Market Surveillance (PMS) strategies that encompass all phases of the product lifecycle.
- Quality Planning: Collaborate in the design of Quality Plans for both hardware and software, ensuring adherence to quality and compliance benchmarks at every project milestone.
- Design Validation: Assess critical design inputs such as usability, reliability, performance, and safety to ensure product excellence.
- Oversight: Provide robust oversight for the execution of quality and reliability plans, risk management activities, and all design-related tasks throughout the product/system lifecycle.
- Technical Assessment: Conduct independent evaluations of product quality performance and post-market analysis to facilitate effective problem-solving and root cause analysis.
- Stakeholder Support: Assist stakeholders during quality system audits and inspections, ensuring compliance and quality standards are met.
- Expertise in Quality Management
- Proficient in Risk Management
- Knowledge of Design Controls and Change Management
- Strong Quality Assurance and Engineering skills
- Experience in Verification and Validation processes
- Understanding of Design Transfer processes
- Bachelor's degree in Engineering or a related field
- At least 3 years of relevant experience in the medical device or regulated industry
- Familiarity with global regulations, requirements, and standards
This position offers a competitive salary of $60/hour along with benefits such as paid sick leave, optional medical/dental coverage, a 401(k) retirement plan, employer-paid life insurance, and short-term disability coverage.
Elyon International, Inc. is proud to be an Equal Opportunity Employer. We welcome applications from all qualified individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
