Quality Systems Specialist III

Position Summary The Quality Systems Specialist III is responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), ensuring compliance with GMP requirements, FDA & ISO standards, and other applicable regulations. This temporary position will support the team through a major project, planned through the end of 2026, with potential for extension or conversion. The base salary range for this role is currently $90,000 to $110,000, with final compensation based on education, relevant experience, skill set, knowledge, and business needs. Responsibilities CAPA process – track, trend, and drive timely completion of approved CAPAs, ensuring appropriate root cause analysis, actions, and verification of effectiveness. Deviation process – track, trend, and drive timely closure of deviations, including approving and closing deviations. Internal Audit program – plan, conduct, report, and transfer nonconformities to the CAPA process, driving timely closure. Quality Agreements – maintain up-to-date files, update agreements to current templates, and communicate with affiliates or distributors regarding status under minimal supervision. Quality Plans – issue, create, track status, and close quality plans in a timely manner. Nonconformance process – assist the Quality Engineering team with tracking, trending, and timely closure. Training program – develop and maintain training materials and deliver training to improve personnel competencies and ensure regulatory compliance. Skills & Capabilities Facilitate meetings related to QS activities, taking minutes as directed. Support change orders/process improvements for QS procedures with management direction. Understand quality consequences arising from improper performance of specific tasks and identify potential device defects across product design, verification, validation, manufacturing, and testing. Provide support for quality assurance activities including regulatory audits and management review. Develop and maintain metrics and KPIs for Quality System activities. Participate in internal, external, and third‑party audits as needed. Operate with a general working knowledge of all Accriva Quality System programs. Assist employees with clear understanding and implementation of regulatory standards. Carry out duties in compliance with established business policies. Interface with all functions and levels of management as needed. Perform other duties as assigned in response to changing business needs. Qualifications Bachelor’s degree in Life Sciences (preferred). Minimum of five (5) years of relevant experience, or two (2) years with an advanced degree. Previous Quality Assurance experience within a GMP regulated environment. Strong understanding of Quality Management Systems. Strong planning, organizational, and time‑management skills. Ability to prioritize urgent matters. Technical Qualifications Good understanding of US FDA Quality System Regulations (QSR). Good understanding of ISO 13485:2016. Good understanding of Good Manufacturing Practices and Good Documentation Practices. Good understanding of change control requirements. Good understanding of record retention. Computer literacy with Microsoft Office (Word, PowerPoint, Excel) and experience with ERP systems such as SAP. Technical writing background/experience. Excellent written and verbal communication skills. Competencies Attention to detail. Accuracy and completeness of records. Outstanding performance standards and meeting departmental goals. Good communication skills. Discretion: honest, loyal, trustworthy. Multitasking and prioritization. Collaboration: active networking for best solutions. Independence and self‑motivation with minimal supervision. Professionalism in all interactions. Initiative: role model for continuous improvement. Problem solving: prompt and effective issue handling. Equal Opportunity Employment 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 View email address on click.appcast.io for assistance. #J-18808-Ljbffr