Lead Quality Systems Specialist

About the role

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.

Responsibilities

• 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.
• Trains other staff members and serves as back-up for the manager when unavailable.
• 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.
• Acts as a back-up subject matter expert and provides assistance to lower-level staff with more complex tasks.
• 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.
• Ensures effective Recall Strategy (includes Customer and internal communications), Recall Tracking, and Recall Termination.
• Responsible for monthly recall status updates to FDA.
• Ensures timeliness of invoice payment submissions on outside vendor services.
• Back-up keynote speaker to PQTF Monthly meetings on C&R Recalls.
• Participates in Product Safety Committee and serves as back-up host.
• Supports FADF, HHA, and Field Action Notification (Safety and Alert) creation activities.
• Back-up for witnessing, documenting, and coordinating recalled material destructions with outside vendors and internal departments.
• Utilizes judgement and discretion to determine when a recall is ready for termination.
• Oversees and maintains all field action campaigns in Access Database.
• Mentors and trains subordinate employees.
• Maintains consignee lists within Access Database.
• Assists with data collection and distribution of FMCNA Field Action Data.
• Responsible for Monthly Recall Tracker meeting with management.

• Ensures timeliness of recall strategies as outlined in approved field action decision.
• Responsible for timeliness of Complaint Related Returned Goods Material (CRM RGA) dispositions.
• Supports all Corporate Quality Holds Department activities including execution, verification, and distribution of hold/dispositions.
• Establishes effective relationships with ORA District Recall Coordinators and vendors to ensure robust recall execution.
• Maintains Pre and Post Market Surveillance industry practice understanding through development trainings.
• Collaborates with sites on Management Responsibility processes, Management Review Process, Quality Planning, ISO Audits, and Regulatory Inspections.
• Responsible for continuous improvement of Corporate Quality Systems MCE policies, procedures, and work instructions associated with the Quality Manual, Management Responsibility, Management Review, Quality Planning, Organizational Structure, and Regulatory Inspections.
• Prepares Corporate Management Review and Corporate Quality Council presentations and meeting minutes; tracks and reports on action items.
• Monitors Management Review process to ensure adherence to procedural requirements and reports to management.
• Establishes efficient and effective processes for collection of management review data across FMCRTG, LLC sites.
• Tracks Management Representatives and Alternate Management Representatives across FMCRTG, LLC sites, ensuring appointment letters are accurate.
• Executes Quality Planning process at corporate location, including tracking of actions against plan deliverables.
• Supports and provides guidance on the Quality Planning process at the corporate and site locations.
• Collaborates with sites to develop metrics and trending data to ensure adherence to the Quality Planning procedural and plan requirements and reports during management review meetings.
• Implements training program for Quality Planning at corporate and site locations.
• Prepares information required for inspections and audits based on level of inspection, commitments, and agendas.
• Participates in various Regulatory Inspections and Audits by interfacing with investigators and auditors; assists front/back office.
• Provides assistance at corporate and site locations with the preparation of regulatory responses, ISO responses, and internal audit responses and associated periodic updates.
• Provides assistance with the documentation, organization, tracking, and maintenance of responses and updates associated with Regulatory citations, ISO findings, and Internal Audit findings.
• Assists with CAPAs assigned to Quality Systems, Management Control Element department.
• Responsible for the overall health, security, and function of the documentation system and provides back-up in SAP Master Data activities as directed.
• Supports the documentation discipline by ensuring the 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 the distribution of Change Notices (CNs).
• Tracks, logs, and distributes CNs to maintain a paper trail for new and revised documents to ensure compliance with regulations.
• Creates Standard Operating Procedures and interacts with various functions of the organization.
• Maintains documentation system with continuous improvement initiatives as identified.
• Ensures all documents are filed in the appropriate location and document control is maintained and effective.
• Performs “Proofing” review during Change Notice (CN) submission/document check-in process to ensure basic requirements are met for specifically required elements.
• Develops/maintains standard document forms/templates to ensure the organization’s needs for documentation infrastructure are met, with compliance to all applicable statutory and regulatory requirements.
• Addresses business and technical support inquiries of Documentation Management System users.
• Develops and provides training across the business as required.
• Provides assistance and guidance to CN originators for new part numbers, BOMs, as well as changes to existing SAP data, or other CNs.
• Coordinates workflow to create, process, and make approved changes to SAP data in CNs.
• Responsible for the 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.
• Designs learning activities and materials; applies knowledge of instructional methods, adult learning theory, and instructional design techniques.
• Develops evaluation and performance measurement tools to measure post-learning knowledge, retention, and behavioral outcomes.
• Develops and implements elements of a competency-based training program (competency mapping, job task analyses, etc.).
• Develops and analyzes KPIs and metrics to evaluate overall program effectiveness.
• Identifies measurable objectives/outcomes and develops instructional materials (presentations, in-class activities, assessments, e-learning modules, documentation, work instructions, OJTs).
• Designs and delivers highly engaging, creative, and effective classroom/online instruction.
• Provides support during FDA and other regulatory body inspections.

Requirements

• Bachelor’s Degree required; Advanced Degree preferred or an equivalent combination of education and experience.
• 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.
• Ability to 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.
• 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).
• Experience in a regulated industry in a documentation/engineering change control environment.
• Basic understanding of Engineering specifications and drawings; AutoCad experience strongly preferred.
• Expert knowledge/understanding of regulatory requirements governing document control preferred.
• Basic knowledge of 21 CFR Part 11 compliance is a plus.
• Experience in Learning and Development or Training environment required.
• Dynamic group presentation skills.
• Strong background in instructional design, development, and delivery strongly preferred.
• Professional quality discipline certification (CQE, CQA, CQM, or RAB) desired.

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 required.