Position Summary:

The Senior Quality System Specialist will be responsible for developing and maintaining a robust quality system in compliance with all relevant standards and regulations. This role will create, deploy and improve quality system processes in support of corporate objectives, and will be directly involved in shaping strategies that will support on-going improvement and effectiveness of the quality system. Other key responsibilities of this role will include monitoring and managing field quality issues, interaction with notified bodies (FDA), and preparation for pending EU MDR regulations.

Primary Duties and Responsibilities:

Quality Management System Compliance:
• Initiate, facilitate and/or manage projects to expand, enhance and improve the quality system.
• Create, review and maintain quality system SOPs, work instructions and other documents.
• Support or coordinate field action investigations and related activities
• Act as liaison for global corporate QMS with counterparts from other facilities.
• Support Notified Body audits, customer/partner audits and FDA inspections.
• Provide quality system training for the organization.
• Lead special projects to enhance and extend the effectiveness of the QMS
Monitoring of External Standards:
• Lead the External Standards Review Board.
• Monitor the release of new standards that may affect Product or the Quality Management System
• Lead efforts to ensure compliance of emerging standards and regulations
• Conduct gap assessments of new regulations and standards, and drive resolution of the gaps to ensure ongoing QMS and Product Compliance.
• Coordinate with Regulatory and other teams to communicate and educate staff on emerging standards that may affect the QMS and the business.
Internal Audit Team:
• Serve as a Lead Auditor for internal audits at the corporate site.
• Support internal audits and supplier audits at domestic and international sites, as needed.
• Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions.
• Interact directly with notified bodies (FDA) on behalf of company
• Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities.
• Work with SME’s to ensure audit record content is accurate, well documented, and meets the requirement of the process.
Corrective and Preventive Action:
• Ensure that all CAPAs are entered into the CAPA system, assigned to the appropriate personnel, and completed according to CAPA procedures and within specified time periods.
• Develop metrics and perform trend analysis of the CAPA process to identify areas for improvement.
• Mentor and coach CAPA owners toward effective investigation and root cause analysis, resulting in CAPA content that is accurate, well documented, meets the requirement of the process, and is completed in a timely manner.
• Own and lead Quality Management System CAPAs, as needed

Minimum
• Bachelor’s degree.
• 5+ years medical device experience including at least 3 years in Quality Management Systems.
• Strong knowledge and hands-on experience with FDA QSR, ISO 13485, EU Medical Device Regulation (MDR), and other national and international regulations (Canada, Japan, China, Brazil, etc.).
• Experience with EU MDR assessment and implementation
• Experience supporting field action activities
• Able to build relationships and work effectively with individuals at all levels of the organization in a collaborative and congenial manner.
• Ability to clearly and concisely articulate ideas both verbally and in writing.
• Demonstrated project management skills to plan, conduct and implement project deliverables
• Proven organizational skills, planning skills and ability to work effectively within teams
• Proven ability to take initiative and ownership in order to move projects or tasks forward to completion
• Ability to shift priorities based on the current business needs and to make progress on multiple, concurrent projects.
• Independent decision-making and problem-solving skills; ability to analyze information, evaluate results and choose the best solution

Preferred
• ISO 13485 Lead Auditor certification

Other
• Mental demands – work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations.
• Travel requirements are moderate. Travel to domestic facilities would be about 2 – 3 days duration each trip, and travel to international facilities would be a week. Total travel expected to be 10% - 15%.