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Job Summary: The Senior Quality Assurance Engineer is responsible to participate in the development of an FDA compliant quality assurance system for medical devices. Primarily responsible is to implement and monitor compliance for in-house product design and vendor management. The Senior Quality Assurance Engineer works closely with design and manufacturing processes. This position does not have any direct reports.
Reports to: Sr. QA/RA Leadership
Job Duties:
- Maintain and manage QA/RA records, including DHF (Design History File), DMR (Device Master Record), and DHR (Design History Record).
- Implement supplier quality processes, product inspection/acceptance activities, nonconformance evaluation and investigation, complaints and related activities.
- Conduct supplier site inspections and audits, supplier qualification activities, and manage supplier QA activities.
- Collaborate with QA/RA consultants to develop and improve documentation processes for in-house product design control and development, and production and process control activities, including supplier quality management, document change processes, process verification and validation, CAPA, risk management, and employee training programs.
- Work collaboratively with other PercuVision departments
Job Requirements:
- Bachelor's degree in a technical discipline or equivalent combination of education and experience in medical device quality systems and/or biomedical engineering.
- Minimum of 3 to 4 years experience with the above-specified responsibilities in a regulated medical device environment.
- Experience with Microsoft Office Suite
- Experience with electronic record-keeping a plus.
- Demonstrated high attention to detail.
- Demonstrated effective interpersonal skills.
- Demonstrated ability to independently execute actions.
- Effective oral and written communication skills and ability to communicate effectively using English.
To apply for the position, please send your resume to employment@percuvision.com
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