Associate Director Quality Assurance
- Raleigh, NC
- Contract
- Full-time
Staff Management
- Responsible for the management of global R&D Quality staff including performance management, training, coaching, mentoring, and task 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.
- Quality activities for medical device manufacturing and Design
- 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.
- 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.
- Oversee audits (e.g., internal, vendor/supplier), as needed.
- Vendors/suppliers qualifications.
- All client regulatory authority inspections and certification body audits, as applicable.
- 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.
- Facilitate and support harmonization initiatives within the R&D group.
- Facilitate and support projects to improve R&D compliance and operational efficiencies.
- 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.
- 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.
- Additional duties as needed to support the business and overall company objectives.
- Articulate a clear and compelling vision aligned with the global cultural tenets and strategic objectives of the company.
- Clearly define roles and responsibilities while holding members accountable for their performance.
- Develop talent and skills of individual team members
- Empower leaders and employees to make informed decisions, enabling autonomy while providing guidance and support.
- Bachelor's Degree in Engineering or Life/Health Sciences; Master's Degree preferred
- Certification(s) - ASQ Certified Quality Engineer or equivalent - preferred
- 7 - 8 years of relevant Quality medical device development experience
- Energy-Based Device Experience
- Knowledge of Class II, 510K, 21CFR 820, ISO 13485, IEC 606011, ISO 14971 experience
- 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
- Ability to travel up to 15%
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