The DAVIS Companies is supporting a global leader in the medical device industry by securing a Quality Engineer to join their team.
This position will be responsible for the implementation and support of process yield improvement projects, process validation, and Operations training activities in such a manner that will meet/exceeds customer requirements for product and service quality and drive compliance with 21 CFR Part 820.
Responsibilities of Quality Engineer:
- Demonstrate knowledge of domestic and international requirements and standards such as FDA QSR Part 820, ISO 14971, ISO 13485, ISO 9001. Support internal, corporate, notified body, FDA, and other audits
- Drive improvements in shop floor quality control processes and procedures
- Drive corrective, preventive, and closure actions for project issues related to quality and/or test nonconformance
- Develop and improve the plant quality organization’s ability to perform complex problem solving to more effectively address customer complaints, service deviations and internal corrective actions
- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary
- Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement
- Assist to develop and confirm methods for reprocessing of assigned devices
- Write verification and validation documentation and conduct required testing as needed
- Perform testing and inspection functions including forensics and root cause analysis
- Author, revise, train, and provide support for production work instructions
- Identify new processing needs and perform continuous improvement to support sustaining efforts
- Participate in Design Reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customers’ specifications/requirements for products
- Support cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and Supplier Quality improvement
- Lead and facilitate process improvement activities and may include project management responsibilities
- Committed to building a positive culture. Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements
Requirements of Quality Engineer:
- B.S. engineering degree preferred
- Device, pharmaceutical, food/beverage Q. A. or other FDA regulated industries may be considered a substitute for education. Certified Quality Auditor and or Certified Quality Engineer preferred
- Minimum of 5 years experience as a process, manufacturing, industrial, operations or quality engineer in a sophisticated manufacturing/operations environment.
- Medical device, pharmacy, bioengineering, food or other FDA regulated industry a plus. Will also consider equivalent electronics, computer, telecommunications , etc experience