The Director, Quality Assurance, is responsible for the global strategic management and oversight of R&D Quality activities and associated staff related to Good Manufacturing Practices (GMP) for non-Energy Based Devices (EBD) and EBD Medical Devices. Activities include, but not limited to general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control, etc. This role will operate as a liaison among the various R&D functions and the Quality Operations department to assure global strategic alignment and compliance.

Essential Duties and Responsibilities: 

• Staff Management: Responsible for the management of 5-10 global R&D Quality staff including performance management, training, coaching, mentoring, and task oversight
• R&D Quality Management and Oversight: Responsible for the global strategic oversight of R&D Quality GMP activities as related to Medical Devices (non-EBD and EBD) in support of Project Teams and R&D overall to assure global compliance. Including:
  • Quality activities for medical device manufacturing and Design & Development activities throughout all stages of the device development process (e.g. general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control)
  • Leading teams through Design Control requirements while maintaining compliant Design History Files and support tech transfers to manufacturing
  • R&D quality oversight of preclinical and clinical planning and readiness activities
  • R&D quality oversight of document reviews and regulatory submissions in support of business objectives
  • Oversee R&D Quality project timelines as defined by department, project team, and business objectives
• Risk Management: 
  • Oversee risk management activities throughout all stages of the device development process
  • Oversee the risk management plan, risk file and risk report for assigned projects
• Human Factors Engineering: 
  • Oversee human factors/usability activities throughout all stages of the device development process
  • Oversee the human factors engineering/usability plan, Use/misuse error analysis, usability task analysis, facilitate formative and validation protocols and report
• Audits:
  • Oversee audits (e.g., internal, vendor/supplier), as needed
    • Vendors/suppliers qualifications
    • all Merz regulatory authority inspections and certification body audits, as applicable
• General R&D Support:
  • Support R&D related activities including but not limited to SOP creation and maintenance, NCRs, DCNs, CAPAs, deviations, change requests, archival, corporate, and departmental initiatives
• R&D Quality Improvements:
  • Facilitate and support harmonization initiatives within the R&D group
  • Facilitate and support projects to improve R&D compliance and operational efficiencies
• Quality Intelligence: 
  • Stay informed of the latest updates related to applicable regulations to ensure R&D Quality policies and procedures remain compliant as related to Medical Devices
  • Provide updates to R&D staff, as applicable
• Further Tasks: 
  • Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriate
  • Provide support to other R&D staff as needed and perform duties and assignments as required
• Other duties as assigned: 
  • Additional duties as needed to support the business and overall company objectives

Job Related Qualifications/Skills

Professional Experience

• Required:
  • Minimum 15 years relevant Quality medical device development experience
  • Energy-Based Device Experience
  • Knowledge of Class II, 510K, 21CFR 820, ISO 13485, IEC 606011, ISO 14971 experience
  • Experience managing a team of 5-10 global staff
• Preferred:
  • Certification(s) – ASQ Certified Quality Engineer or equivalent

Knowledge, Skills, and Abilities

• Required:
  • Proficient in all MS Office applications
  • Demonstrated organizational skills, ability to independently prioritize work and detail oriented
  • Strong verbal, written communication, and emotional intelligence skills
  • Ability to effectively multitask and manage multiple projects
  • Experience with FDA, European agency regulations, cGMP regulations, and Quality Management software is highly preferred
  • Knowledge of regulatory requirements and standards for a medical device organization (i.e., 21CFR820, ISO 13485, ISO 14971, IEC 62304)
  • Ability to work effectively in a global, matrix environment
• Preferred:
  • Ability to travel up to 15%

Education:

• Required: 
  • Bachelor’s Degree in Engineering or Life/Health Sciences
• Preferred:
  • Master’s Degree