Posting ID: JP-002639216
They are a global medical device company. They focus on promoting internally and are a very high performing team. There is a ton of visibility in the Quality department & exposed to different departments / all areas.
Job title: Quality engineer
- Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
- Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
- Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
- Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.
- Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
- Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
- Coordinate product testing with internal and external laboratories as required.
- Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
- Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
medical device, statistical analysis, process validation, pharmaceutical, quality engineering, design control
Additional Skills & Qualifications:
- BA degree in engineering related field
- 3+ years of medical device OR pharmaceutical experience
- 3+ years of statistical analysis experience
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The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072