Senior Quality System Specialist II

Overview 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. Responsibilities Key Accountabilities Essential Functions: The Senior QS Specialist II will be expected to support all activities within the Quality Systems team shown below but will have primary responsibility for maintenance, improvement and leadership of at least one or two of the following: 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 Secondary Functions: 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 Networking/Key Relationships: To be determined based on department needs, to include interactions such as: All Werfen Departments Werfen Affiliate QARA Werfen Corporate and other Werfen Manufacturer QARA Qualifications Minimum Knowledge & Experience Required for the Position: Education : Minimum of bachelor’s degree, in related scientific or technical field Experience : Minimum 10 years (or 7 years with advanced degree) of experience in the medical device, IVD or other regulated industry Additional Skills/Knowledge: 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 Lean/Six Sigma experience, or equivalent certification/education/experience is a plus Minimal Leadership Skills required Strong understanding of change control requirements Strong understanding of record retention Skills & Capabilities: Attention to Detail : Strong Ability to pay close attention to detail is required Accuracy : Work is accurate and completeness of records Outstanding Performance Standards : Demonstrated strong ability to meet department goals Ethics and Values: must demonstrate Integrity and Trust / Ability to be Discrete Delivery of Results (Action Orientation) : Strong ability to Learn on the Fly / Taking Initiative Communication : Strong written and verbal communication skills Discretion: Acts Honest, Loyal, Trustworthy Multi-Tasking : Strong planning, organizational and time management skills are required to support changing business needs Collaboration : Strong ability to work with cross functional teams Independence : Must be self‑motivated and have the ability to work under minimal supervision; must also be able to work as part of a team Professionalism : Must demonstrate professionalism during all interactions within company, customer and third parties Takes Initiative : Strong ability to drive continuous improvement, correct deficiencies and to prevent recurrence Problem Solving: Strong problem‑solving skills are required Travel Requirements: 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