Here is a brief job description:
In this role you will participate in the PQMS integration activities from a sustaining Design Assurance Engineering perspective. Your primary role will revolve around the creation and execution of quality transition plans for legacy Drug Coated and Specialty Balloon products.
You are responsible for:
• Participating in the integration activities of quality system procedures, work instructions, templates and forms.
• Working across sites to understand the product specific quality system regulatory requirements, and constraints of different business units, while putting together quality transition plans for legacy products.
• Working cross functionally with Q&R, R&D, and Operations to carry out quality transition plans on legacy products, from a Design Assurance perspective.
• Providing training to changes in quality system procedures to sustaining and new product development teammates.
To succeed in this role, you should have the following skills and experience:
• Bachelor’s Degree is required. Engineering degree (preferred).
• 5+ years of experience in medical device industry.
• Must have experience in applying Design Controls and Risk Management using a life cycle approach.
• Experience in test method validation and statistics.
• Working knowledge of 21 CFR 820, ISO 13485 and ISO 14971.
• Exposure to working within multiple quality systems.
• Proven problem-solving skills, ability to execute on quality transition plans and effectively communicate across sites.
• Ability to influence effectively without direct authority across an organization.
• Ability to travel up to 25% is required