Apply on Employer Site

Werfen · 1 month ago

Specialist I, Quality Systems

US-CA-San Diego

Full-time

Onsite

Entry Level

$33.65/hr - $40.87/hr

2+ years exp

Werfen is a company focused on quality assurance and regulatory affairs, and they are seeking a Quality Systems Specialist I. The role involves assisting in the planning and improvement of the Quality Management System to ensure compliance with GMP requirements and regulatory standards.

Health CareHospitalManufacturingMedical Device

H1B Sponsor Likely

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 3rd 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

Quality Management SystemGMP complianceFDA regulationsISO 13485 2016Enterprise Resource PlanningTechnical writingRecord retentionPlanning skillsChange controlMicrosoft OfficeOrganizational skillsTime management

Required

Minimum of two (2) years relevant experience or one (1) year related experience with an advanced degree

Previous Quality Assurance experience within a GMP-regulated environment

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)

Basic understanding of ISO 13485:2016

Good understanding of Good Manufacturing Practices & Good Documentation Practices

Basic understanding of change control requirements

Computer literacy

Good working knowledge of Microsoft Office programs, especially Power-point

Preferred

Bachelor's degree (Life Sciences)

Experience with Enterprise Resource Planning (ERP) system (such as SAP)

Technical writing background/experience

Company

Werfen

Glassdoor4.0

Werfen is a developer, manufacturer and distributer of IVD testing solutions.

Founded in 1966

Barcelona, Catalonia, ESP

5001-10000 employees

http://www.werfen.com/

H1B Sponsorship

Werfen 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)