Primary Objective: Provide design assurance (DA) leadership and direction for all Nonin Medical product lines and business initiatives. Lead and manage DA team to support achievement of business objectives. Define and implement design quality, design assurance engineering and quality test strategy and roadmap. Determine and define design assurance requirements to stakeholders throughout the company. Support the quality engineering, quality assurance and quality system compliance functions in order to mutually achieve overall departmental and business objectives.
Essential Job Functions
Ensure company products and operations comply with applicable regulatory standard requirements including FDA QSR, ISO 13485 and EU MDR/MDD requirements with emphasis on design control, design quality and quality engineering requirements.
Lead and manage design assurance department resources to support achievement of business objectives.
Oversee design assurance departmental budget.
Drive design quality, product development and quality engineering process improvements and updates using continuous improvement approach.
Facilitate achievement of business objectives using risk-based approach while ensuring QMS compliance within the flexibility of the regulations. Collaborate with executive management in determining departmental organizational plan, operating model, strategy deployment and governance procedures.
Direct and enable compliant, efficient and risk-based execution of product verification and validation, translation of voice-of-customer/clinical use environment into design inputs, verification and safety testing and certification, external standards control and compliance, design and use failure mode analysis, risk management process, reliability engineering/design-for-reliability, and DHF ownership and maintenance.
Provide support to quality engineering, quality assurance and quality system compliance functions in order to mutually achieve departmental and business objectives.
Develop and grow high-performing team to support design assurance activities; facilitate organizational cohesiveness with the Nonin operating model, business strategy and culture of quality and compliance.
Lead efforts for QMS remediation activities if necessary.
Collaborate with executive management in determining departmental organizational plan, operating model, strategy deployment and governance procedures.
Participate on project teams to provide design assurance leadership and input.
Support inspections and audits by customers and applicable regulatory agencies including FDA and notified EU notified body.
Drives new product development quality strategy including identification of applicable standards, design verification testing and human factors engineering.
Maintains and manages favorably the relationship with third party test labs for external testing and certification.
Required Education & Experience:
Bachelor's Degree in a scientific, engineering or related technical discipline.
6+ years of experience with increasing responsibility within the quality/design assurance/regulatory/compliance discipline in the life sciences industry.
2+ years of management experience in regulated industry.
Required Knowledge, Skills & Abilities:
Demonstrated history of successful quality and compliance organizational leadership and successful achievement of organizational business objectives.
Knowledge of applicable regulations and standards in the areas of the FDA QSR, ISO 13485, ISO 14971, IEC 60601-1 and EU MDR/MDD.
Strong written and verbal communication skills, especially when dealing with regulatory agencies or certification bodies.
Ability to explain and resolve differences in interpretation of standards, regulations and quality system and design quality requirements.
Demonstrated experience in development, deployment and execution of quality and compliance strategy.
Advanced degree and/or professional certification in quality/regulatory/compliance.