What are the responsibilities and job description for the Senior Quality Engineer position at Cynet Systems?
Job Overview
Pay Range: $54.18hr - $59.18hr
Responsibilities
Pay Range: $54.18hr - $59.18hr
Responsibilities
- Perform quality engineering activities supporting product development and cleanroom build operations.
- Ensure New Product Development (NPD) processes comply with quality systems and applicable regulatory standards.
- Update and maintain risk management and design control documentation.
- Develop and execute test method validations and qualification plans.
- Support design verification, process validation, and commercialization activities, including multi-site transfers.
- Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory, Clinical, and Marketing.
- Maintain accurate and compliant quality documentation aligned with internal and external standards.
- Contribute to continuous improvement initiatives and quality assurance processes.
- Perform additional duties as assigned by leadership.
- Bachelor s degree in Engineering or a Scientific field with 4 years of experience, OR
- Master s degree (or equivalent) in Engineering or a Scientific field with 3 years of experience.
- Strong understanding of engineering and quality principles, theories, and concepts.
- Experience in product development, quality assurance, or related fields.
- Knowledge of ISO 13485 standards.
- Experience maintaining risk management files and design control documentation.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills with strong attention to detail.
- Ability to manage multiple priorities in a fast-paced environment.
- Experience in medical device manufacturing or operations.
- Hands-on experience with test method development, validation, and fixture development.
- Basic understanding of statistical techniques and experience with tools such as Minitab.
- Ability to build strong cross-functional relationships and work collaboratively across teams.
- Strong organizational and documentation skills.
- Attention to detail with a focus on quality and compliance.
- Effective stakeholder communication and teamwork.
- Ability to handle competing priorities and deliver results under pressure.
Salary : $54 - $59