- Investigate and process medical device complaints and maintain open complaint level to acceptable levels.
- Assist in maintaining quality system information databases as assigned. Evaluate quality data and prepare periodic reports to monitor trends.
- Assist in supporting manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
- Process non-conforming material reports including MRB dispositioning.
- Assist in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations.
- Develop, implement, and/or maintain instructions/methods for inspecting, testing and evaluating product conformance to specification.
- Support Engineering in the development, testing, verification, validation and commercialization of new products.
Education + Experience
- B.S. in Engineering Related Field
- 3+ years related quality assurance, quality engineering experience or an equivalent combination of experience and education. Medical device experience preferred.
- Experience investigating and processing medical device product complaints
- ASQ certification a plus.
- Intermediate knowledge of FDA Quality System Regulation 21 CFR Part 820.
- Good organizational, attention to detail and follow-through skills
- Excellent verbal and written communication skills
- Ability to interface with multiple groups in the organization.
- Systems - Basic computer skills - word processing, spreadsheet, windows. MS Office preferred.
- Willingness to contribute to other departments as necessary.