Staff Quality Systems Specialist

Werfen•San Diego, CA

2d•$100,000 - $125,000•Remote

About The Position

The Staff Quality Systems Specialist is a senior-level individual contributor responsible for supporting the compliance, effectiveness, and continuous improvement of the Quality Management System (QMS). The position serves as a Quality System subject matter expert and partners with cross-functional stakeholders to ensure quality processes and activities comply with applicable regulatory requirements, international standards, and company procedures. The role provides leadership through quality systems expertise, collaboration, project coordination, and influence rather than direct authority. The Staff Quality Systems Specialist supports the development, deployment, monitoring, and continuous improvement of QMS processes and programs, facilitates inspection readiness activities, coordinates Quality Plans (QPPs) as applicable, monitors quality system performance and compliance metrics, and drives implementation of digital quality system solutions and process enhancements.

Requirements

Bachelor’s degree in life science, engineering, or equivalent required.
Ten (10) or more years of Quality Systems and/or Quality Assurance experience in a regulated environment required; Quality Systems project management experience is highly preferred.
Eight (8) or more years of work experience in In Vitro Diagnostic (IVD) or medical device industry required.
Advanced knowledge of current compliance requirements (e.g., US Quality Management System Regulations (QMSRs), EU In Vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, or other regulations and standards).
Advanced knowledge of project management tools and methodologies including project life cycle, Gantt charts, change management, and risk assessment and mitigation.
Strong knowledge of business environment and relationship to projects and initiatives, business unit/group function, and cross group dependencies/relationships.
Advanced ability to interpret and apply compliance and quality systems requirements.
Advanced ability to organize and complete multiple tasks in a fast-paced environment as a team member and/or as an individual contributor in a timely, accurate manner under general supervision.
Advanced ability to lead, collaborate and influence cross-functional teams to achieve common goals, without direct authority.
Advanced ability to effectively manage multiple concurrent projects and proactively identifies and mitigates barriers to success.
Advanced ability to function effectively with ambiguity in a rapidly changing environment.
Advanced ability in influencing and negotiation while building collaborative relationships and maintaining strong, positive working relationships.
Advanced ability to independently identify, assess risk for, and develop proactive and creative approaches to barriers to success.
Advanced ability to independently identify, assess risk for, and mitigate.
Advanced skills in verbal and written communication including presenting.
Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, PowerPoint, Visio, and Adobe Acrobat.

Nice To Haves

Advanced degree preferred.
Certified Medical Device Auditor, preferred.
Six Sigma/Green Belt certification, preferred.
Project Management Professional (PMP) certification preferred.
Experience applying project management methodologies, Lean Six Sigma principles, and metrics/statistical reporting is highly preferred.

Responsibilities

Administers assigned Quality System processes and programs (e.g., External Documents, CAPA, Internal/External Audit, QPPs, eTraining) to ensure ongoing compliance, effectiveness, and continuous improvement of the Quality Management System.
Monitors process performance and quality metrics, identifies trends and opportunities for improvement, and supports the implementation and maintenance of quality procedures, controls, and reporting mechanisms.
Collaborates with cross-functional stakeholders and subject matter experts to drive process enhancements, ensure required documentation and training materials are maintained, and leverage data-driven insights to improve quality system performance, efficiency, and compliance.
Monitors and manages applicable regulatory requirements, industry standards, guidance documents, and other external quality requirements to ensure ongoing compliance of the Quality Management System.
Facilitates cross-functional impact assessments of new and revised external requirements, drives implementation of resulting action plans, and maintains inventories of applicable standards and regulatory requirements.
Ensures effective communication, alignment, and collaboration with the Regulatory Affairs regulatory intelligence process to support timely evaluation, interpretation, and implementation of evolving external requirements across the organization.
Leads and coordinates Quality Project Plans (QPPs) and Quality System improvement initiatives to enhance compliance, efficiency, and effectiveness across the organization.
Drives cross-functional projects of moderate to high complexity, establishing project plans, monitoring milestones, risks, and deliverables, and ensuring successful execution within defined timelines and objectives.
Supports the implementation and continuous improvement of Quality processes, systems, and digital solutions, including SAP-based enhancements, while providing project status, recommendations, and leadership to stakeholders to achieve sustainable business and quality outcomes.
Represents QRC and Autoimmunity on inter- and intra- company projects and initiatives.
Develops and administers Quality Systems training materials to promote compliance with QMS requirements, regulatory standards, and company procedures.
Leads quality compliance awareness initiatives (e.g., World Quality Week), new hire quality training, and maintains training materials and learning resources to ensure effectiveness, consistency, and continuous improvement.
Supports the implementation and optimization of digital learning and training management systems to enhance training compliance, tracking, reporting, and overall effectiveness.
Manages internal and third-party audits, regulatory inspection preparation and execution.
Assists in the timely closure of audit findings by providing quality guidance for investigations and supporting the implementation of resulting corrections, corrective actions, and preventive actions (CAPAs).
Ensure compliance with applicable AID standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies
Reflects the values of Werfen and AID in the quality of work and in working relationships.