Quality Team Lead

About the role

Shift: Week day Mon.-Fri. 7:00am-3:30pm

Responsibilities

• Provide direction and coordination to quality associate and quality clerks relative to specific quality focus areas - Customer Claims, Shipping Audits, Quarantine and Non-Conforming Product (Holds, SIQ, Returns, Damage).
• Assist Quality Supervisor and/or Manager in preparing procedures, work instructions, shipping papers and any other duties assigned to meet requirements.
• Implement and monitor all procedures and processes as they relate to Customer Claims, Shipping Audits, Quarantine, Hold, Expired, Damages, Return Goods and Recalled product
• Ensures the accurate and actionable audit, custom claims, product hold and quarantine processes and records for the making of decisions.
• Ensure compliance to Document and Record Control procedures.
• Responsible for assuring products are placard, stored and distributed in a manner that meets their product requirements and prevent unsaleable conditions prior to shipment to customers
• Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements and continuous improvement.
• Understand, track, and trend Quality department Key Performance Indicators.
• Review operating goals and standards on a daily basis to monitor achievement.
• 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.
• Create and maintain documents in accordance with the Document Control Procedure, Work Instructions, Regulatory Compliance documentation, corrective action and other related forms and records.
• Participate in internal/external quality audits and report findings.
• Duties include creating monthly management reports, including internal and external reports.
• Damage Subject Matter Expert, providing feedback to DC personnel on damage standards and training as needed.
• Other duties as assigned

Position Requirements

Experience

• A minimum of 5 years relevant experience in Quality, Supply Chain and/or Distribution Center operations, preferable in Medical Device and/or Pharmaceutical regulated industry
• Supervisory experience a plus
• Working knowledge and application of ISO 13485 and 21 CFR 820 preferred
• Computer skills (Excel, Word, Power Point, etc.)
• Minimum of 2 years Material Handling Equipment experience

Competencies

• Excellent communication, problem solving, organizational and interpersonal skills are essential.
• Ability to understand FDA, EPA, DOT and OHSA rules and regulations
• Self-motivated and directed, requiring minimal supervision
• Demonstrated ability to work in teams to obtain results is required.
• Effective skills in analytical thinking and problem solving required

Education

• High School diploma required
• Associate Degree preferred