Principal Eng, Quality Assurance

Education And/or Experience

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

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

Qualifications

• Proven understanding of compliance requirements across medical device and drug product development, including change control, NCR CAPA, and risk management.
• Strong written and verbal communication skills
• Strong interpersonal/communication/influencing/negotiation skills required.
• Demonstrated leadership, teamwork, and communication abilities, with a record of achieving results with large teams.
• Device regulation (design control) experience required
• Working knowledge of FDA regulations (21 CFR Part 210, 211, 820, 803, 806), ISO 13485, ISO 14971, IEC 60601, and applicable 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.
• Proficiency with Minitab or an equivalent statistical analysis tool is required.
• Proficient in managing product and process change controls and risk management
• Use DMAIC and statistical methods to resolve issues and support investigations
• Shows the ability to work independently
  
  

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 sustainment of safe and effective medical devices
• Owns Quality Assurance responsibilities for the Product Development and Lifecycle Management process.
• Supports product verification testing to confirm product reliability and conformance to specifications
• Organize and implement site support for 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
• Evaluates data from multiple sources (Non-Conformances, Field Corrective Actions, Medical Device Reports, and Complaints) to inform and drive decisions
• Promote a Quality culture mindset and provide input for code quality improvements.
• Lead and oversee targeted process/product improvement initiatives, including test case adequacy, requirement levelling, and test automation.
• Reasonable Accommodation
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