Edgepark is one of the fastest growing companies in Northeast Ohio and the industry leader in home-delivered medical supplies. We specialize in providing diabetes, ostomy, wound care and urological products to patients nationwide. With our corporate headquarters in Twinsburg, Ohio, we encompass seven distribution centers across the country, a workforce approaching 1,000 and sales exceeding $700 million annually. Our success is driven by a focus on efficiency, the willingness to improve and an unrelenting commitment to succeed.

General Position Summary:

• Responsible for the development, application and management of quality control procedures for globally purchased finished goods as well as business process development and continuous process improvement
• In charge of ensuring products to be distributed are free from flaws and meet required quality standards
• The position is responsible for documentation and compliance as it relates to FDA medical device and drug regulatory requirements
• Provides quality oversight to global suppliers through direct communication or in the form of deviations and/or Corrective Action Requests
• Functions to resolve deviations and investigations of customer complaints. 

 
Key Responsibilities & Duties:

QUALITY CONTROL

• Develop new quality policies and Standard Operating Procedures for private label products and distribution thereof
• Develop, initiate and manage methods and procedures for inspection, testing (including third-party testing) and evaluation for all products to ensure products meet quality requirements; includes quality control for final audit inspections, in-process inspections, incoming receiving inspections, and quality acceptability guidelines
• Supervise overseas/domestic audits to ensure proper documentation to meet FDA requirements is available, accurate and prompt; submit appropriate response to deficiencies and Corrective Action Requests
• Review finished product, product packaging and labeling to ensuring compliance with quality control and FDA requirements
• Root-cause and provides quality oversight to suppliers through direct communication or in the form of deviations and/or Corrective Action Requests
• Interact with Category Management, Customer Service, Supply Chain, Legal, FDA Consultants, and Compliance to ensure prompt and effective response to quality issues
• Lead bi-weekly Quality Review Meeting with Asia and Domestic Teams and report on current relevant issues; participate in internal team meetings
 
CONTINUOUS IMPROVEMENT
 
• Support continuous improvement initiatives by creating/revising models and methodologies to drive efficiencies
• Lead multiple, cross- functional and/or cross-departmental projects and initiatives
• Identify the key process or value stream
• Map the Current State of the process or value stream
• Define and identifying key measures and performance targets
• Develop solutions to critical business issues and presents alternatives
• Map the Future State of the process or value stream
• Communicates project status to sponsors, stakeholders
• Implement the Future State plans

Experience & Knowledge:

• Expertise with quality management tools, concepts and methodologies
• 3-5 years of quality experience in a manufacturing environment
• Ability to develop and implement quality policies and process improvement procedures to promote efficiencies
• Facilitate troubleshooting and learning with other managers, other departments, supervisors, and manufacturers
• Ability to form and lead short duration teams to achieve successful goals
• Experience in LEAN concept practices a plus
• Ability to analyze data, conduct statistical analysis and grasp the key point for complicated details
• Eye for detail and strong desire for continuous improvement
• Expertise working with Legal, Regulatory, and Compliance to ensure products and packaging meet FDA regulatory requirements
• Self-starter, able to manage multiple projects/priorities, work effectively with minimal guidance, ability to influence others
• Effective negotiation, communication and report writing skills; experience in direct communication with customers and suppliers
• Ability to travel abroad (passport required)
• Ability to speak Mandarin a plus
• Proficient using MS Office software

Education Requirements:

• Bachelor’s degree and/or equivalent work experience required
• 4-year college degree in manufacturing and/or engineering related field of study preferred
• Lean Process Improvement Certification a plus

We offer new hire paid training, career path planning, medical/dental/vision benefits, paid vacation beginning your first year of employment, paid service hours for charity participation, 401(k), on site fitness center and profit sharing. 

                                An Equal Opportunity/Affirmative Action Employer M/F/D/V