Werfen North America · 1 week ago
Specialist I, Quality Systems
San Diego, CA
Full-time
Onsite
Entry Level
$33.65/hr - $40.87/hr
2+ years expWerfen North America is seeking a Quality Systems Specialist I to assist in the planning, coordination, control, and continuous improvement of the Quality Management System. The role involves supporting various quality processes and ensuring compliance with regulatory standards.
Health CareManufacturing
Responsibilities
The QS Specialist I will be expected to support some of the activities within the Quality Systems team shown below but will have primary responsibility for at least one of the following:
CAPA process – tracking, trending of approved CAPAs, and driving timely /appropriate completion of activities
Deviation process – tracking, trending, and driving timely /appropriate closure
Internal Audit program –transfer of any nonconformities issued to the CAPA process and driving timely /appropriate closure
Quality Plans – issuing number, tracking status, appropriate closure
Quality Records – scan, inventory, archive and retrieve quality records; maintain off-site master inventory list
Design Control – support the DHF/DCR creation, maintenance, and archival process; conduct DHF/DCR reviews/audits; act as an independent reviewer during design review
Quality Systems Activities:
CAPA
Deviation process
External Document process
Quality Agreements
International QMS compliance with Werfen Affiliates
Quality Plans
Training program
Helps facilitate meetings related to QS activities by taking minutes as directed
Supports change orders/process improvements with respect to Quality Management System procedures with direction from management
Provides support to quality assurance activities for regulatory compliance, ( i.e., Management Review support, Regulatory audits)
Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs
Participates in internal, external and/or 3 rd party audits, as needed
Provides support through a general working knowledge of all Werfen Quality System programs
Aids employees based on a clear understanding and implementation of regulatory standards
Carries out duties in compliance with established business policies
Interface with all functions and levels of management as needed
Maintain the accuracy , legibility, traceability and retrieval of quality documents and records
Other duties as assigned, according to the changing needs of the business
Qualification
Required
Bachelor's degree (Life Sciences) preferred
Minimum of two (2) years relevant experience or one (1) year 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 are required
Ability to prioritize urgent matters
Basic understanding of US FDA Quality System Regulations (QSR) is required
Basic understanding of ISO 13485:2016 is required
Good understanding of Good Manufacturing Practices & Good Documentation Practices
Basic understanding of change control requirements
Computer literacy required; good working knowledge of Microsoft Office programs, especially Power-point required
Preferred
Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred
Technical writing background/experience is a plus
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase