
Medical Device Design Assurance Specialist
5 hours ago
Design Assurance Lead
About the Role:
This is a leadership position responsible for ensuring the quality of our products. As Design Assurance Lead, you will be the point person for quality-related matters and will work closely with cross-functional teams to establish and maintain design history files.
- Evaluate material biocompatibility and sterilization methods during product design cycles.
- Lead risk assessments to determine design functionality.
- Implement Corrective and Preventative Actions (CAPA), change control, and notification procedures.
- Audit and qualify suppliers as needed.
- Collaborate with customers and suppliers in a professional manner.
Responsibilities:
- Manage customer relationships and responses.
- Develop strong manufacturing process instructions and operator training.
- Conduct product verification and validation activities.
- Maintain compliance with company Quality Manual requirements.
- Identify improvement opportunities and implement changes.
Requirements:
- Bachelor's degree in Engineering or related field.
- 6+ years of medical device design and development/quality assurance experience.
- Proven ability to lead cross-functional teams.
- Excellent communication and interpersonal skills.
- Demonstrated ability to manage multiple projects simultaneously.
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