Medical Device Quality Specialist
3 weeks ago
Job Summary: We are seeking a highly skilled Senior Service Development Quality Engineer to join our Global Capital Equipment (CE) Quality Assurance team. As a key member of our Service Development Quality Engineering group, you will provide Service Development Quality Engineering support to both Service Development and Field Service Engineering, ensuring that the highest quality products are delivered to customers.
About the Role: The Senior Service Development Quality Engineer will be responsible for assisting product and service development teams to ensure the development and commercialization of top-quality products, directly impacting BSC's customer experience. Key responsibilities include reducing and controlling service process nonconformances, developing and implementing service quality plans, and creating quality tools and training materials.
What You'll Do:
- Reduce and control service process nonconformances by leading efforts/teams focused on 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 in conjunction with other product development team members.
- Develop and implement product performance monitoring by identifying critical service processes and devising methods to reduce nonconformances in order to reduce/eliminate issues impacting product reliability.
- Collect and analyze field product performance by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance service processes, sustaining product design, and new product development.
- Create Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
Requirements:
Education: Bachelor's degree in Industrial, Biomedical, Mechanical, Electrical Engineering, or related field
Experience: Minimum 5 years of experience in medical device engineering
Skills and Qualifications: In-depth knowledge of FDA, ISO, MDD, EU MDR, and medical device industry quality requirements; excellent technical writing skills;
Travel: Less than 10% travel required if necessary.
Benefits:
• Comprehensive compensation package
• Opportunities for career growth and development
• Collaborative and dynamic work environment
• Recognition and rewards for outstanding performance
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