Principal Eng, Quality Assurance

Education And/or Experience

BS Degree (engineering, science or pharmaceutical related discipline) with 8 -10 years of experience in medical device industry

Experience in the design and development of electromechanical devices is required.

Qualifications

• Demonstrated compliance knowledge in medical device and drug product development, including change control, NCR CAPA, and risk management.
• Strong verbal and written communication skills
• Strong interpersonal/communication/influencing/negotiation skills required.
• Demonstrated leadership, teaming, and communication skills, accomplishing success with large teams.
• Device regulation (design control) experience required
• Knowledge of FDA (21 CFR Part 210, 211, 820, 803, 806), ISO 13485, ISO 14971, IEC 60601, and standards for medical devices and therapeutics.
• Strong analytical and problem-solving skills using DMAIC tools; Six Sigma Engineering and ASQ or other certifications are desirable.
• Proficient with Minitab or any equivalent statistical tool is required.
• Proficient in product and process change controls and risk management
• Apply DMAIC and statistical techniques to address issues and investigations
• Demonstrates ability to work independently
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Essential Duties And Responsibilities

Provides quality guidance and approval for product design and process change controls to ensure compliance with the required Product Development Process (PDP) deliverables, supporting the development and ongoing delivery of safe and effective medical devices

Responsible for Quality Assurance of the Product Development and Lifecycle Management process.

Supports product verification testing to ensure product reliability and conformance to specifications

Organize and implement site support of corporate audits and Notified Body regulatory inspections. Serve as front room lead for audits and inspections.

Educates and trains on product body of knowledge and Vantive QMS principles

Analyzes data from various sources (Non-Conformances, Field Corrective Actions, Medical Device Reports, and Complaints) to drive decision-making

Drive a quality culture mindset and provide input for code quality improvements.

Identify and oversee specific process/product improvement initiatives, including test case adequacy, requirement levelling, and test automations.

Reasonable Accommodation

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