Specialist I, Quality Systems at Werfen GmbH

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Apr, 26

Salary

40.87

Posted On

18 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GMP Regulations, ISO 13485:2016, Good Manufacturing Practices, Good Documentation Practices, Change Control, Record Retention, Planning, Organizational Skills, Time Management, Technical Writing, Microsoft Office, ERP Systems, CAPA Process, Deviation Process, Internal Audits

Industry

Medical Equipment Manufacturing

Description

Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. 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. Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Responsibilities

The QS Specialist I will assist in the planning, coordination, control, and continuous improvement of key components of the Quality Management System. Responsibilities include managing CAPA and deviation processes, supporting audits, and maintaining quality records.