Responsible for Product Quality Engineering activities providing high level of hands-on technical engineering support of the product life cycle, from NPI to commercialization and post-market evaluation in a cross-functional, multi-disciplinary environment. Responsible for all aspects product related to the quality of the Visby’s product platform, as well as Quality System processes to establish and maintain compliance to all applicable regulatory requirements. The right candidate has reagent-based diagnostics, electro-mechanical engineering experience and the ability to take on technical challenges through resolution
- Establish and lead the Product Quality group to include design engineering and quality operations supporting manufacturing
- Responsible for assuring projects meet customer expectations, and regulatory requirements including FDA Quality System Regulations 21CFR Part 820, and Risk Management per ISO 14971
- Manages standards compliance to include, but not limited to, IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle to product development and sustained engineering projects
- Directs & serves as a Quality Assurance core-team representative on one or more project teams engaged in new product development, quality processes improvements, business system implementations or other special projects
- Applies statistical tools to analyze data and identify trends, root cause and drive correction, and corrective actions to resolution
- Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
- Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
- Drive design control processes improvements and risk assessment exercises in support of validation activities
- Consider the application of privacy, security, environmental, health and safety standards.
- Assist and participate in internal and external audits, including supplier audits.
- Coach and influence a positive culture of quality within the team and across the company
- Maintain a safe, organized, and clean work environment.
- Other duties as assigned
Education and/or Experience
- Bachelor’s Degree in an applied science or engineering field
- Minimum of 10 years of experience in Quality Assurance of class II or III with embedded software in the medical device/diagnostics field with a minimum of 5 years of management experience
- Demonstrated competency with 21 CFR 820, ISO 13485, ISO 14971, and other international standards
- Exceptional problem-solving and organizational skills
- Ability to understand and explain complex quality issues to non-experts
- Knowledge and experience with ERP/MRP systems and their applications preferred
- Excellent written and interpersonal communication skills.
- Comfortable performing repetitive tasks and/or motions.
- Must be able to lift a minimum of 10 lbs.