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: