Essential Duties and Responsibilities:
- Responsible for implementing and managing multiple QMS within site.
- Analyzes data from various sources (Non-Conformances, Field Corrective Actions, Medical Device Reports, and Complaints) to drive decisions
- Partner with R&D leadership at site and segment level to develop and deploy strategies to assure excellence in site implementation of the product development process.
- Responsible for Quality Assurance of the Product Development and Lifecycle Management process.
- Utilizes DMAIC tools to promote a disciplined nonconformance investigation approach and participates in corrective and preventive actions (CAPA)related activities, including CAPA ownership if appropriate
- Drive Quality culture mindset and provide input for code quality improvements.
- Responsible for on-site training on Design controls, Product Security and Verification & Validation.
- Identify and oversee site wide software specific process product improvement initiatives such as test case adequacy, requirement levelling and test automations.
- Manages interactions with and responses to Ministry of Health inquiries and support submission files.
- Provides quality guidance and approval to product design and process change controls to ensure compliance to the required Product Development Process (PDP) deliverables, resulting in the development and sustaining of safe and effective medical devices
- Supports product verification testing to ensure product reliability and conformance to specifications
- Gather regulatory intelligence and implement requirements and best practices into site processes.
- Organize and implement site support of corporate audits and Notified Body regulatory inspections. Act as front room lead for audits and inspections.
- Oversee internal audit program to assure complaint to Vantive QMS.
- Educates and trains peers or subordinates on product body of knowledge and GMP principles
Qualifications:
- Demonstrated compliance knowledge in the areas of medical device and drug product development, 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
- Demonstrated skills in navigating the product security and software development standards and regulatory requirements.
- Knowledge of FDA (21 CFR Part 210, 211, 820, 803, 806), ISO 13485, ISO 14971, IEC 60601, ICH, EMEA, and CFDA regulations and standards for medical devices and therapeutics.
- Strong analytical and problems solving skills utilizing DMAIC tools, Six Sigma Engineering, ASQ or other certifications 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 leadership skills and ability to work independently
- Ability to organize and present technical information with minimal assistance
Education and/or Experience:
- BS Degree (engineering, science or pharmaceutical related discipline) with 12-14 years of experience in medical device industry or MS Degree with 8-10 years of experience in medical device industry.
- 5-7 years of leadership experience is preferred.
- Experience in the design and development of software and/or electromechanical devices is required.
