Specialist I, Quality Systems at Werfen GmbH

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Feb, 26

Salary

40.87

Posted On

14 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, GMP Compliance, FDA Standards, ISO Standards, CAPA Process, Deviation Process, Internal Audit, Quality Plans, Quality Records, Design Control, Regulatory Compliance, Change Control, Microsoft Office, Technical Writing, Planning Skills, Organizational Skills

Industry

Medical Equipment Manufacturing

Description

Overview 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), which helps to ensure compliance to GMP requirements, FDA & ISO standards, and other regulations as they 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 for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs. This is a full-time, temporary position through June 2026. Responsibilities Key Accountabilities 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. Qualifications Minimum Knowledge & Experience required for the position: 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. Skills & Capabilities: 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. Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred. Technical writing background/experience is a plus.

Responsibilities

The QS Specialist I will assist in the planning, coordination, control, and continuous improvement of the Quality Management System to ensure compliance with GMP requirements and regulatory standards. Primary responsibilities include managing the CAPA and deviation processes, supporting internal audits, and maintaining quality records.