Primary Objective. The Sr. Manager of Operational Quality assures operational quality excellence and compliance for all Nonin Medical product lines and business initiatives. Lead and manage Quality Engineering teams to support achievement of operational quality and overall business objectives. Define and implement quality processes to support and enable production operations. Determine and define operational quality requirements to stakeholders throughout the company.
Essential Job Functions
Senior leader with responsibility and accountability for assuring conformance to requirements in operational processes
Ensure operations comply with applicable regulatory standard requirements including FDA QSR and ISO 13485 requirements
Lead and manage Quality Engineering (Product, Manufacturing, Supplier) teams and resources to support achievement of operational quality and overall business objectives
Oversee Operational Quality departmental budget
Implement industry-standard quality processes to support and enable production, supplier and complaint-analysis processes
Drive operational quality process improvements and updates using continuous improvement approach
Facilitate achievement of business objectives using risk-based approach while ensuring compliance within the flexibility of the regulations.
Direct and enable compliant, efficient and risk-based execution of operational quality engineering processes including complaint handling and analysis, manufacturing process validation, design transfer, sustaining/continuation engineering, post-market surveillance, storage/preservation of product, non-conforming product, supplier quality, receiving and first article inspection, and environmental/materials compliance
Develop and grow high-performing team to support operational quality activities; facilitate organizational cohesiveness and cross-functional cooperation within the Nonin operating model, business strategy and culture of quality and compliance
Support efforts for QMS remediation activities, if necessary
Participate on project teams to provide operational quality leadership and input
Collaborate with executive management in determining departmental organizational plan, operating model, strategy deployment and governance procedures
Facilitate and manage inspections and audits by applicable regulatory agencies including FDA and EU notified body.
Required Education & Experience:
Bachelor's Degree in a scientific, engineering or related technical discipline
10+ years of experience with increasing responsibility within the quality/regulatory/compliance discipline in the life sciences industry
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 in the areas of the FDA QSR, ISO 13485 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 requirements.
Demonstrated experience in development, deployment and execution of quality and compliance strategy.
Advanced degree and/or professional certification in quality/regulatory/compliance
Understanding of external regulations FDA 21 CRF part 820, ISO 13485, MDD/MDR
Experience with Complaint Handling processes and Complaint investigations
Strong skills with data analysis and statistical software such as Minitab, or similar
Six Sigma Green or Black Belt
Sit, and/or stand 8 hrs/day
Nonin offers an impressive total compensation package including competitive salaries, comprehensive benefits with medical, dental, vison, company paid life, AD&D, short and long term disability, profit sharing and a generous 401(k) employer match.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.