- Establish goals, provide work direction, manage performance, and develop talent for the team of Quality Engineers, Inspectors, Technicians, and Supervisors.
- Ensure that design control criteria are met throughout new product development.
- Produce high-quality deliverables in accordance with project deadlines.
- Provide experience in requirements flow-through, risk management, reliability, test method creation, validation, and design verification and validation to cross-functional development teams.
- Oversee the development and maintenance of quality programs, systems, processes, and procedures, particularly in the areas of production and process controls, receiving, inspection, calibration, nonconforming product management, environmental monitoring, process validation, quality records, and change control.
- A bachelor's degree in science or a related field is necessary, with a preference for biomedical, electrical, or mechanical engineering.
- 5+ years of work experience in Quality Engineering with a significant degree of knowledge is necessary.
- 3+ years of expertise in the manufacture of medical devices or product development
- Understanding of FDA (21CFR820) and ISO (13485/14971) regulations
- Understanding of quality improvement technologies, such as statistical methodologies
- ASQ Certified Quality Engineer (CQE) and Certified Quality and Organizational Manager (CMQOM) recommended
- About 10% of the time, domestic and foreign travel is necessary.
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Quality Engineering Manager - Bothell, United States - Pikemann LLC
Description
Pikemann is searching for a Quality Manager (Engineering)Location: Burnaby, BC Canada / Bothell, WA
The Quality Manager (Engineering) is in charge of providing Quality Engineering leadership in direct support of medical device product development and production operations.
Responsibilities:
