Senior Quality System Specialist II

Werfen•San Diego, CA

13h•$120,000 - $150,000•Remote

About The Position

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. Position Summary: Responsible for the planning, coordination, control, and implementation of continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. The focus of the position is to assist in maintaining and monitoring key Quality Systems. Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key project support under the supervision of the Quality Systems Manager. The annual base salary range for this role is currently $120,000 to $150,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

Requirements

Minimum of bachelor’s degree, in related scientific or technical field
Minimum 10 years (or 7 years with advanced degree) of experience in the medical device, IVD or other regulated industry
Previous Quality Assurance experience within a GMP regulated environment required
Strong understanding of US FDA Quality System Regulations (QSR), ISO 13485:2016, Good Manufacturing Practices & Good Documentation
Strong computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) required
Minimal Leadership Skills required
Strong understanding of change control requirements
Strong understanding of record retention
Strong Ability to pay close attention to detail is required
Work is accurate and completeness of records
Demonstrated strong ability to meet department goals
must demonstrate Integrity and Trust / Ability to be Discrete
Strong ability to Learn on the Fly / Taking Initiative
Strong written and verbal communication skills
Acts Honest, Loyal, Trustworthy
Strong planning, organizational and time management skills are required to support changing business needs
Strong ability to work with cross functional teams
Must be self-motivated and have the ability to work under minimal supervision; must also be able to work as part of a team
Must demonstrate professionalism during all interactions within company, customer and third parties
Strong ability to drive continuous improvement, correct deficiencies and to prevent recurrence
Strong problem-solving skills are required

Nice To Haves

Lean/Six Sigma experience, or equivalent certification/education/experience is a plus

Responsibilities

CAPA process – tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate
Internal Audit program – planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit.
Quality Agreements – maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision
Quality Plans – issuing number, creating plan, tracking status, timely/appropriate closure
External Documents – tracking, trending of the External Document process. Driving timely/appropriate initiation and completion of Action Plans.
Management Review – Support the creation and delivery of the Management Review presentation. Support completion and approval of the Management Review Meeting Minutes and closure of Action Items.
Training program – focusing on improving the competencies of personnel to ensure compliance with regulatory requirements and written procedures by creating and maintaining training materials and delivering training as needed.
Facilitates and leads meetings related to QS activities
Supports and leads change orders/process improvements with respect to Quality Management System procedures with direction from management
Develop and maintain a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs
Participate in internal, external (including regulatory) and/or 3rd party audits, as needed
Carries out duties in compliance with established business policies
Provides assistance and recommendations based on a clear understanding and implementation of regulatory standards
Interfaces with all functions and levels of management as needed
Other duties as assigned, according to the changing needs of the business