Senior Quality Systems Specialist

About the Role

We are looking for a detail-oriented, proactive professional with a strong foundation in quality regulations and standards, the ability to manage competing priorities, and the communication skills to engage effectively across all levels of the organization. The Senior QMS Specialist partners closely with cross-functional stakeholders — spanning Manufacturing, CAPA, Supplier Quality, Audit and Regulatory Affairs — to ensure alignment with quality system requirements and regulatory expectations.

A Day in the Life

• Review and drive QMS changes to support product and process releases and updates, sourced from local and enterprise level.
• Use excellent verbal and written communication skills to communicate and collaborate.
• Build and maintain positive relationships across the organization with strong relationship skills and act as a quality partner to other groups.
• Coordinate with team members, manager and other stakeholders to support both day-to-day activities and long-term goals.
• Contribute to QMS quality by identifying, collaborating, creating and/or completing process improvements changes.
• Support monthly and quarterly quality metric reviews (as well as others) by facilitation, communicate, review and recording.
• Use critical thinking and data analysis to identify outliers or concerns and act to resolve.

Responsibilities

• Reviews and facilitates development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance to co-workers in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Supports audit and inspection preparation, resolution of audit and inspection findings through all stages of the audits.
• Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
• Leads or supports compliance related activities like audit readiness, Corrective and Preventative Actions (CAPA), process improvement.
• May act as back-up for software validation or other quality activities as needed.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Required Knowledge and Experience

• Requires a Baccalaureate degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
• Requires experience in Quality Management Systems, including Change Management, Continuous Improvement and CAPA.
• Requires experience in usage of Microsoft office Suite – especially Word, Excel, PowerPoint, etc.

Nice to Have

• Mastery of a specialty area and knowledge of industry practices, typically obtained through advanced education combined with experience.
• Experience in the medical device industry with relevant regulatory and standards knowledge is strongly preferred.
• Direct experience with Audit Backroom and/or Front Room roles, non-product computer system validation, regulations/standards assessment, translation coordination, and/or multi-site/QMS entity coordination would be welcome.
• May have broad knowledge of project management or process improvement methodology.
• Six Sigma, Kaizen, PMP or other project management certification a bonus.
• Experience with software systems: Agile, Trackwise, Microsoft Teams, Project, PowerBI, etc.