Quality Assurance Specialist
3 weeks ago
Overview of Job Responsibilities
">This role will involve working closely with clients to identify and meet their quality engineering and quality management system (QMS) needs.
">- Lead the administration of device design and change management, ensuring that quality controls and design changes meet requirements.
- Conduct process risk management for novel and existing medical devices (PFMEA).
- Develop, document, and validate inspection and test methods to support design control Process Validation, in-process inspection, and final inspection activities.
- Bachelor's degree in software engineering or life sciences.
- 4-6 years of relevant experience in medical devices, including experience mentoring/training other engineers.
- Strong knowledge of medical device regulations and standards, including ISO 13485, ISO 14971, and ISO 62304.
The estimated annual salary for this position is $140,000 - $200,000, depending on qualifications and location.
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