Quality Assurance Director- Healthcare jobs in Atlanta, GA

Description

Position: Director of Quality Assurance/Technical Services

Location: Remote with travel to Asia-based suppliers as-needed

World Centric is a highly mission driven company that seeks to have a meaningful impact on people and planet through our compostable products and the donation of 25% of profits to the most vulnerable in the world. For more information on working and life at World Centric, please visit our website .

The Director of Quality Assurance is responsible for the Global Quality Management System, and all associated KPI’s and reporting for the function.   This role will ensure product quality, safety, and regulatory compliance for all manufacturing at partner sites.  

They will be responsible for  everything related to quality including specifications, processes, controls, systems,  supporting overseas manufacturing sites and leading the quality team. They will develop, implement, maintain, and continual improvements to the organization’s quality management system & process to minimize defects and quality issues. They will provide quality Assurance oversight in the production process, ensuring that products, materials, batch records, and labeling adhere to current Good Manufacturing process (cGMPs) and other internal and external regulations and standards. An ideal detail-oriented candidate will demonstrate a proactive approach (bias toward action) with commitment to achieving Zero Defects.

This leadership role centers on the strategic and operational execution of Quality Assurance and Quality Control, key responsibilities include but not limited to:

Responsibilities

• Develop, implement, and communicate quality policies, standards, and procedures with suppliers to ensure consistency and alignment with Quality objectives.
• Implement process controls and supplier surveillance plans to oversee and mitigate risks of product quality defects.   
• Establish and maintain processes and systems for product launch readiness at suppliers to ensure production meets compliance and product specifications
• Oversee, manage, and report on  corrective action requests and audit processes with suppliers.
• Perform root cause analysis of failed parts.  Identify problems due to manufacturing conditions, design tolerances or other reasons.  Ensure parts meet technical specifications
• Manage/hire QC personnel as needed for onsite inspection/validation.
• Recommend/Evaluate QMS and Vendor Management Systems
• Assess and monitor GMP and regulatory compliance risk areas and develop/implement risk mitigation measures.
• Track and report key GMP quality management system performance metrics and KPI’s. Report and escalate compliance issues as needed.
• Manage supplier certification / compliance tracking documents and ensure Certifications are current and accessible. 
• Analyze metrics/KPI’s to prepare supplier scorecards for supplier quarterly business reviews.
• Continuous review of processes to improve efficiencies and quality.
• Lead all quality, safety and reliability requirements for Product Development and Sourcing Teams.
• Oversee  day-to-day oversight and support of product complaint and recall processes.
• Oversee periodic testing of products for functionality, compliance, and conformance as required and document with samples. 
• Stay abreast of changing global and region-specific regulations, standards, and customer requirements to anticipate potential future impacts to processes or product.
• Ensure that product date code revisions are managed.  Maintain a master list of all date codes and revisions by sku.

Requirements

• Minimum of 10-15 years or more combined experience in Quality Assurance, preferably in Packaging or Food/ CPG industry.
• Strongly Preferred: 5 years of experience as quality manufacturing engineer
• Bachelor’s Degree in a technical field
• Prior experience with ISO9001, 14001, BRC, HAACP, GFSI and/ or other standards needed.
• Experience working with Asia-based factories and resource
• Experience with high volume manufacturing.
• Experience with compression molding, injection molding, thermoforming, extrusion, coating, paper converting processes a plus
• Strong analytical skills, experience with Project Management tools, Excel, and PowerPoint required.
• Experience with Product Lifecycle Management (PLM) and QMS software
• Experience using ERP Systems with Oracle Netsuite experience a plus.
• Excellent written, verbal and presentation skills in English are required with Mandarin being a plus

Physical and Travel Requirements

• Preference is for this role to work out of Atlanta on a hybrid basis but will consider applicants throughout the US. 
• Travel to Asia for supplier reviews minimum twice per year and occasional travel to offices or warehouse locations as-needed

World Centric welcomes applicants from all backgrounds and aims to find the people who not only meet the requirements of the job but also contribute to the culture in a way that recognizes our efforts towards the overall wellbeing of people and planet.