Medical Device Quality Assurance Specialist
hace 2 meses
Merit Medical Systems Inc. seeks skilled professionals to develop lifesaving medical devices that improve lives worldwide. Our goal is to integrate and develop individuals who want to build through hard work, teamwork, and commitment, devices that save lives. Together, we're making a difference in the lives of patients worldwide.
About Merit Medical Systems Inc.We strive to provide innovative solutions for the healthcare industry. Our company culture emphasizes the importance of collaboration, dedication, and continuous improvement.
Job DescriptionThis role involves independently evaluating, selecting, and applying standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. The successful candidate will ensure containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
- Evaluate and participate in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required.
- Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
- Ensures the continued suitability and effectiveness of the quality management system through the use of: quality policy, quality objectives, audit results, analysis of data, etc.
- Evaluates the work environment in which product is manufactured, and ensures it is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
- Performs other related duties and tasks as required.
The estimated salary for this position is around $120,000 per year, depending on experience and qualifications.
Required Skills and QualificationsTo be successful in this role, you should have a Bachelor's Degree in Engineering or a related field, with at least five years of quality engineering experience. You should also have strong interpersonal, organizational, and verbal and written communication skills, and the ability to work effectively as a team member.
- Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.
- Proven ability to work effectively in a team environment through conflict resolution and negotiations.
- Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Mert Medical Systems Inc. offers competitive benefits including life insurance, major medical expenses, funeral expenses, extended medical benefits, paid time off, superior vacation and holiday pay, 2 days of floating birthday leave, 2 additional holiday days, and a savings plan.
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