Werfen North America
Specialist I, Quality Systems
Werfen North America, San Diego, California, United States, 92189
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Specialist I, Quality Systems
role at
Werfen North America
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.
Key Accountabilities
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.
Qualifications Minimum Knowledge & Experience required for the position
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.
Skills & Capabilities
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.
Seniority Level Entry level
Employment Type Temporary
Job Function Quality Assurance
Industries Medical Equipment Manufacturing
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Specialist I, Quality Systems
role at
Werfen North America
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.
Key Accountabilities
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.
Qualifications Minimum Knowledge & Experience required for the position
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.
Skills & Capabilities
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.
Seniority Level Entry level
Employment Type Temporary
Job Function Quality Assurance
Industries Medical Equipment Manufacturing
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