Lead Quality Systems Specialist

Responsibilities Acts as a subject matter expert to support the organization with initial compliance and ongoing preparation, testing, and monitoring of conformance to established quality systems processes and standards for manufacturing and production. Resolves a wide range of issues in creative ways. Performs high level evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Provides training to other staff members. Serves as a back‑up for the manager when the manager is not available. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Receives little instruction on day‑to‑day work and general instructions on new assignments. Acts as a back‑up subject matter expert and provides assistance to lower‑level staff with more complex tasks that require a higher level of understanding of functions. Escalates issues to supervisor/manager for resolution, as deemed necessary. Mentors other staff as applicable. Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations. Assists with various projects as assigned by a direct supervisor. Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. Physical Demands and Working Conditions The individual will, for the most part, be seated and work at a computer and utilize telephone equipment. Travel may be required, as necessary. Lift document files up to 40 pounds. Education Bachelor’s Degree required. Advanced Degree preferred or an equivalent combination of education and experience. Experience and Required Skills 6 – 8 years’ related experience or an equivalent combination of education and experience. Highly autonomous with minimal supervision required. Self‑starter with the ability to work well both independently and as part of a small team. Can prioritize tasks accordingly. Very detail‑oriented, well organized, and driven to meet deadlines and program goals. Strong verbal and written communication skills. Good computer skills with knowledge of Microsoft Office including Access, email platforms, ERP software, and Microsoft Outlook. Ability to work in a high stress environment given the nature and process. Ability to generate moderately complex spreadsheets with graphs for trending data and presentations. Knowledge and application of metrics and charts for quality system processes. Excellent project prioritization, planning, and management. Experience and required skills: Prior corrections and removals experience required. Proficient understanding of USA, Health Canada and Mexico regulations. Strong knowledge of FDA regulatory requirements (21 CFR Part 820/210/211 and Part 11). Knowledge of ISO 13485 and Canadian Medical Device Regulations (CMDR). Prior experience with Regulatory inspections (back office, front office). Basic knowledge of 21 CFR Part 11 compliance is a plus. Expert knowledge/understanding of regulatory requirements governing document control preferred. Knowledge of Documentation Management Sciences/Mil‑Specifications. AutoCad experience strongly preferred. Education: Professional quality discipline certification (CQE, CQA, CQM or RAB) desired for Management Control Element role. Additional Functional Areas Recall Strategy: Ensures effective Recall Strategy (includes Customer and internal communications), Recall Tracking, and Recall Termination; responsible for monthly recall status updates to FDA; back‑up keynote speaker to PQTF Monthly meetings on C&R Recalls. Field Action: Supports FADF, HHA, and Field Action Notification (Safety and Alert) creation activities; back‑up witnessing, documenting, and coordinating recalled material destructions with outside vendors and internal departments; oversees and maintains all field action campaigns in Access Database. Documentation: Responsible for the overall health, security, and function of the documentation system; supports the documentation discipline by ensuring integrity, accuracy, completeness, and quality of documentation and compliance to regulatory guidelines; maintains company documentation including appropriate change control functions; assists in expediting approval and distribution of Change Notices (CNs); develops standard document forms/templates. Training: Responsible for design, development, delivery, and evaluation of both traditional classroom and e‑learning instruction; manages projects and provides guidance and support to other staff; conducts ongoing and comprehensive Learning Management System (LMS) training needs assessments; applies knowledge of instructional methods, adult learning theory, and instructional design techniques; develops evaluation and performance measurement tools. E‑Learning Development: Responsible for design, development, delivery, and evaluation of e‑learning instruction; designs learning activities and materials; applies knowledge of instructional technologies (enterprise LMS, e‑learning course development); experience working in a regulated industry and/or in the delivery of GxP or Quality Systems training a plus. Benefits Annual Rate: $94,700 - $157,000.00. Comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave. Fresenius Medical Care maintains a drug‑free workplace in accordance with applicable federal and state laws. EEO Statement Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non‑merit‑based factors. #J-18808-Ljbffr CH01 CHE Fresenius Medical Care (Schweiz) AG