Quality Assurance Auditor Ii | Device Quality Control Specialist
hace 2 semanas
Merit Medical Systems Inc. is a leading medical device company dedicated to developing innovative products that improve lives.
We are seeking an experienced Device Quality Control Specialist to join our team in ensuring the quality and safety of our medical devices.
Job Summary:
The Device Quality Control Specialist will be responsible for auditing the production process, verifying that Device History Records are completed according to Device Master Record/QSR/GMP regulations, and ensuring that finished products meet specifications.
Main Responsibilities:
- Audit the production process to confirm that Device History Records are completed according to Device Master Record/QSR/GMP regulations.
- Audit finished products to ensure that they conform with Device History Records/applicable specification and procedures.
- Complete final inspection paperwork.
- Perform work order reviews for ECN's, EPWO's, NC's, etc.
- Document inspections/rejections on inspection paperwork.
- Segregate product when discrepancies are noted.
- Initiate and ensure closure of NC's.
- Accountable for the disposition agreement/verification of NC's.
- Operate complex testing equipment in verifying that final product meets specifications.
- Perform dimensional inspections.
Requirements:
To be successful in this role, you should have:
- A minimum of three years of related work experience with one of the years being in quality assurance/quality control work experience.
- Demonstrated knowledge of business mathematics.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
- Excellent attention to detail and the ability to meet deadlines in a timely manner.
- Communication and interpersonal skills and the ability to work well with others.
What We Offer:
At Merit Medical Systems Inc., we offer a competitive salary range of $60,000 - $80,000 per year, depending on experience, as well as:
- A comprehensive benefits package, including health insurance, life insurance, and retirement savings plan.
- Ongoing training and development opportunities.
- A fun and dynamic work environment.
About Us:
Mert Medical Systems Inc. is a global leader in the development, manufacture, and distribution of innovative medical devices. Our mission is to develop products that make a difference in patients' lives.
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