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Principal Service Development Quality Engineer
2 months ago
The Principal Service Development Quality Engineer will play a crucial role in our expanding Global Capital Equipment (CE) Quality Assurance team within the Service Development Quality Engineering group. This position provides Service Development Quality Engineering support to both Service Development and Field Service Engineering, ensuring the highest quality products are delivered to customers.
Key Responsibilities- Lead efforts to reduce and control service process nonconformances by identifying primary root causes and implementing corrective and preventative actions.
- Develop and implement service quality plans, documents, and systems by supporting the creation of service plans, product-specific service processes, and service risk analysis.
- Develop and implement product performance monitoring by identifying critical service processes and devising methods to reduce nonconformances.
- Collect and analyze field product performance by gathering quality metric data and performing analysis to enhance service processes.
- Create Quality Tools & Training Materials by applying expertise and communicating to respective teams.
- Evaluate the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
- Participate in Global Installation and Servicing community of practice to identify opportunities and drive improvements.
- Support BSC teams across functions, product technologies, and cultures to support teams around the globe.
- Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Support and lead improvement projects to sustain the Quality Strategy.
- Provide direction, coaching, and mentoring for service development quality engineering and technical team personnel.
- BS in Industrial, Biomedical, Mechanical, Electrical Engineering, or related degree.
- Minimum of 7 years of medical device engineering experience.
- In-depth familiarity with the FDA, ISO, MDD, EU MDR, and medical device industry quality requirements.
- Solid technical writing skills.
- Travel