Quality Specialist I

Quality Specialist I

Requirements

• BS Degree preferred, or related discipline or equivalent work experience
• ISO 13485 and 21 CFR 820 Lead Auditor certified preferred
• Experience in Supply Chain and/or Distribution Center Operations preferred
• Knowledge and experience in a regulated environment; experience in medical devices and/or pharmaceutical regulated industry preferred
• Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820 preferred
• Computer skills (Excel, Word, Power Point, etc.)
• Process oriented, Continuous Improvement Experience
• Strong people leadership including developing, coaching, listening, collaborating, and delegating
• Excellent organizational, analytical and process efficiency skills
• Excellent interpersonal and communications
• Project leadership skills
• Initiative and drive for result

Responsibilities

• Oversee and assure the DC maintains a robust, standardized and effective Quality System which complies with applicable regulatory requirements and Quality Agreements established with business units served.
• Responsible for leading local site implementation of annual Quality Objectives and Key Business Drivers established for DC operations.
• Ensure the DCs’ processes, organization, procedures, and activities are adequate to effectively meet the needs of the US Supply Chain and conform to all applicable regulatory requirements and regional standards.
• Promote a culture of Quality across the local organization that ensures management commitment and understanding of ISO and QSR regulations as they apply to Storage, Distribution and Transportation.
• Ensure effective implementation and execution of Quality processes conducted under the Quality Systems to accomplish expected requirements and performance.
• Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business.
• Lead and/or participate in regularly scheduled Quality Leadership calls to ensure timely implementation of agreed upon actions and facilitate cross site exchange of performance and synergistic activities.
• Employ and share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues.
• Maximize the benefits for the overall system to drive Business, Supply Chain performance and customer satisfaction.
• Responsible for managing and maintaining an effective local Quality organization, training, development programs, subject matter expertise, defining and assigning associates’ responsibilities, succession plans, establishing annual IIG’s and evaluating performance.
• Serves as a Designated Representative as appropriate to ensure day to day operations meet states’ licensing requirements for medical device and/or wholesale drug distribution regulations as applicable.
• Accountable for Quality System as the local Subject Matter Expert (SME), providing guidance and training, facilitating meetings, escalation and ensuring compliance to the following Quality Systems as assigned: Document and record control, DMS Administrator, Training & Curricula / C2C DLA / GMP & GD, Order Fulfillment Claims support for root cause analysis and SCARs, Intracompany Claims, QMS Audits, Metric Data Analysis, Non-conforming processes, Supplier Management.
• Assist in the execution of CAPAs, Validations, Calibration, and Environmental Monitoring.
• Designated business unit Quality representative for facilitation of remediation/rework activities with DC personnel. Provides on-site training on behalf of the business units on rework protocols when required.
• Partner with Operations and Supply Chain Relations on customer related issues and driving claims to resolution where escalation is needed.
• Conduct and participate in audits as required in compliance with regulatory requirements, e.g. ISO 13485, 21 CFR 820.

Preferred Qualifications

• BS Degree preferred
• ISO 13485 and 21 CFR 820 Lead Auditor certified preferred
• Experience in Supply Chain and/or Distribution Center Operations preferred
• Knowledge and experience in a regulated environment; experience in medical devices and/or pharmaceutical regulated industry preferred
• Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820 preferred