Design Assurance Quality Specialist
2 weeks ago
We are a global leader in medical science, dedicated to solving challenges that matter most. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient outcomes and create value for our customers.
Estimated Salary: $85,000 - $110,000 per year
Our salary estimates are based on industry standards, taking into account factors such as location, experience, and qualifications.
Job Description:
We are seeking a Design Assurance Quality Specialist to join our Quality team. This role will work closely with New Product Development teams to ensure risk management is applied and design controls are adequate. The successful candidate will have strong problem-solving skills, excellent communication abilities, and a deep understanding of quality principles and regulatory requirements.
Your Responsibilities Will Include:
- Identifying and implementing effective controls to support product development and maintenance
- Developing a comprehensive understanding of Design Controls, Risk Management, and Usability for Medical Devices
- Applying repeatable problem-solving concepts to drive quality improvement
- Collaborating with cross-functional teams to enhance quality and compliance
- Participating in design quality assurance and compliance improvement projects
Required Qualifications:
- Bachelor's degree in Biomedical Engineering, Mechanical, Electrical Engineering, or a related field
- 1+ year of experience in the Medical Device Industry
- Strong written and verbal communication skills
- Ability to travel (less than 25%)
Preferred Qualifications:
- Six Sigma problem-solving methodologies
- Knowledge of ISO 13485, ISO 14971, and IEC 60601
- Medical imaging experience
Benefits:
We offer a comprehensive benefits package, including health insurance, retirement savings, and paid time off. As a member of our team, you will have access to ongoing training and development opportunities to help you grow in your career.
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