Company Type
Medical Device Manufacturer
Location
Palo Alto, California
Job Description
- Manages plant quality staff across quality systems and product quality.
- Oversees the quality and documentation system and quality records program.
- Responsible for execution of Design Verification and Process Validation for site projects.
- Manages QMS processes for management review, CAPA, and internal audit.
- Manages and provides resources for quality engineering, supplier quality, inspection, measurement, and test, complaint handling, non-conforming product and MRB resolution.
- Ensures procedural compliance to FDA QSR, ISO, MDD and other applicable requirements.
- Acts as site Management Representative for the TEM quality system.
- Five or more years of quality management and leadership experience in managing multiple departments in quality and/or engineering support functions.
Job Skills
- Background in medical device manufacturing..
- Regulatory affairs experience.
- Technical discipline or quality professional training.
- Statistical techniques, metrology, and process analysis training.
- Quality system design and implementation experience.
- Risk management training.
- Regulatory requirements and reporting responsibilities.
- Supply chain development and management.
- Demonstrated ability to effectively organize, prioritize and accomplish multiple tasks, make decisions and solve problems independently.
- Thorough knowledge of 21 CFR 820 and ISO 13485.
Job ID: 4820
