Specialist , Quality Systems

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The Quality Systems (QS) Specialist I is responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), ensuring compliance with GMP requirements, FDA & ISO standards, and other regulations that pertain to the QMS.

The pay range for this position is currently $33.65-$40.87 hourly. Individual compensation is based on the candidate’s qualifications, including experience, skills, knowledge, education, certifications, internal equity, and business needs.

This is a full‑time, temporary position through June 2026.

• Support activities within the Quality Systems team, with primary responsibility for at least one of the following:
  • CAPA process – tracking, trending, and driving timely completion of approved CAPAs.
  • Deviation process – tracking, trending, and facilitating timely closure.
  • Internal Audit program – transfer nonconformities to CAPA and drive closure.
  • Quality Plans – issue, track status, and ensure closure.
  • Quality Records – scan, inventory, archive, retrieve, and maintain off‑site master inventory list.
  • Design Control – support DHF/DCR creation, maintenance, archival, conduct reviews/audits, and act as independent reviewer during design review.
• Quality Systems Activities, including CAPA, Deviation, External Document, Quality Agreements, International QMS compliance with Werfen affiliates, Training program, and facilitation of related meetings.
• Support change orders and process improvements within the QMS procedures under management direction.
• Assist with quality assurance activities for regulatory compliance, such as Management Review and Regulatory audits.
• Develop and maintain metrics for Quality System activities, including data for Management Review and KPIs.
• Participate in internal, external, and 3‑rd party audits as needed.
• Maintain general working knowledge of all Werfen Quality System programs.
• Aid employees with regulatory standards implementation.
• Carry out duties in compliance with business policies and interface with all functions and management levels.
• Ensure accuracy, legibility, traceability, and retrieval of quality documents and records.
• Perform other duties as assigned, based on changing business needs.

• Bachelor’s degree (Life Sciences) preferred.
• Minimum of two (2) years of relevant experience or one (1) year of related experience with an advanced degree required.
• Previous Quality Assurance experience within a GMP‑regulated environment required.

• Good understanding of record retention.
• Strong planning, organizational, and time management skills.
• Ability to prioritize urgent matters.
• Basic understanding of US FDA Quality System Regulations (QSR) and ISO 13485:2016.
• Good understanding of Good Manufacturing Practices & Good Documentation Practices.
• Basic understanding of change control requirements.
• Computer literacy with a good working knowledge of Microsoft Office programs, especially PowerPoint.
• Experience with an Enterprise Resource Planning (ERP) system (such as SAP) preferred.
• Technical writing background/experience is a plus.

Entry level

Temporary

Quality Assurance

Medical Equipment Manufacturing