Staff Quality Systems Specialist

Werfen is a growing family-owned innovative company founded in 1966 in Barcelona Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis Acute Care Diagnostics Transfusion Autoimmunity and Transplant. Through our Original Equipment Manufacturing (OEM) business line we research develop and manufacture customized assays and biomaterials. We operate directly in 30 countries and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe and our workforce is more than 7000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas our commitment to customers and our dedication to innovation and quality. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

Key Accountabilities

• Quality System Compliance: 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.
• External Documents Control Management: 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.
• Quality Projects and System Improvements: 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.
  
• Training: 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.
  
• Audit: 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).in
  
• 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.
  

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• Manufacturing teams
  
• Regulatory teams
  
• R&D teams including Manufacturing Technical Support
  
• Quality Assurance
  
• Product Testing
  
• Product Complaint Group
  
• Senior Management
  
• Other Werfen Affiliate and Manufacturers functions

Minimum Knowledge & Experience required for the position:

Education

• Bachelors degree in life science engineering or equivalent required. Advanced degree preferred.
• Certified Medical Device Auditor preferred.
• Six Sigma/Green Belt certification preferred.
• Project Management Professional (PMP) certification preferred.

Experience

• 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.
• Experience applying project management methodologies Lean Six Sigma principles and metrics/statistical reporting is highly preferred.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• 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.

The annual base salary range for this role is currently $100k to $125k. Individual employee compensation will ultimately depend on factors including education relevant experience skillset knowledge and particular business needs.

This role is eligible for medical dental and vision insurance 401k plan retirement benefits with an employer match as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management and select professional roles are eligible for a performance-based bonus.

Travel requirements:

Limited to no travel required.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.