Acute Care, Assays, Auditing, Biology, Change Control, Coaching, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Distribution Channel, Document Control, External Audit, FDA (Food and Drug Administration), FDA Requirements, Healthcare, Hemostasis, Hospital, ISO (International Organization for Standardization), Internal Audit, Leadership, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing Technology, OEM (Original Equipment Manufacturer), Operational Strategy, Patient Care, Process Improvement, Project/Program Management, Quality Assurance, Quality Management, Quality Metrics, Regulations, Regulatory Requirements, Reporting Skills, Risk Management, Supply Chain, Surveillance, Systems Administration/Management, Systems Maintenance, Technical Support, Vendor/Supplier Evaluation, Willing to Travel
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 7,000 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. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Overview:
Job Summary
- Responsible for leading and maintaining the Quality Systems & Compliance function for the Norcross Transfusion site. Provides strategic and operational leadership for the Quality Management System (QMS), ensuring sustainable compliance with applicable FDA Quality System Regulation (QMSR), ISO 13485, IVDR, MDSAP, and other global regulatory requirements.
- Accountable for Quality Systems governance, document control, training compliance, internal audits, supplier quality oversight, CAPA governance, management review, inspection readiness, quality met-rics, and continuous improvement programs.
Responsibilities:
Key Accountabilities
- Own and maintain the site Quality Management System (QMS).
- Lead Document Control, Internal Audit, Inspection Readiness, and Management Review programs.
- Provide governance of Deviations, Nonconformances, CAPA, Change Control, and Risk Management.
- Lead Supplier Quality governance and supplier audit activities.
- Develop and report quality metrics and compliance indicators.
- Drive continuous improvement initiatives utilizing Lean and Six Sigma methodologies.
- Lead and develop a high-performing Quality Systems & Compliance team by fostering engagement, accountability, collaboration, and continuous professional development to achieve quality, compli-ance, and business objectives.
- Partner cross-functionally to ensure lifecycle quality integration.
Networking/Key relationships
The purpose of the interactions with the listed departments is to promote quality Quality System, Compliance, and Inspection Readiness. This role interacts with the following departments:
- Manufacturing Operations
- Manufacturing Technical Support
- Laboratory Services
- Design & Sustaining Quality
- Regulatory Affairs
- Post-Market Surveillance
- Supply Chain
- Engineering
Qualifications:
Minimum Knowledge & Experience required for the position:
- Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Business, or related disci-pline.
- 8+ years (Manager) or 10+ years (Sr. Manager) in Quality Systems, Compliance, QA, or Regulatory Affairs within a regulated environment.
- Leadership experience required
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:
- Expert knowledge of FDA QMSR, ISO 13485, IVDR, MDSAP, auditing, CAPA, and quality systems.
- Strong leadership, coaching, communication, and project management skills.
- Experience leading inspections and external audits.
Travel requirements:
Travel is required less than 10% of the time.
Closing:
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 individual’s 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 NAtalentacquisition@werfen.com 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 7,000 employees around the world comprise our Werfen team.
www.werfen.com