Quality Coordinator

General Summary:

Supports Drucker’s mission to make people safer, healthier, and more productive through disciplined development, implementation, and maintenance of the organizations Quality Management System. Builds upon and preserves the integrity of a respected quality assurance program to promote confidence that manufactured goods and services meet the highest standards of quality. 

Essential Duties and Responsibilities:

• Develop, maintain, and improve quality assurance policies and procedures to ensure compliance with all ISO 13485 and FDA CFR 21 Part 820 regulations
• Communicate quality standards to QA team and applicable internal partners
• Review and approval of process and product changes
• Assist in the development of product quality plans
• Participate in all audits of the Quality Management System (ISO, FDA, Customer)
• Collaborate with all levels of the organization to resolve critical quality matters
• Grow professional capability through pursuit of continuous education and training
• Support Quality Engineering by assisting in root cause investigations to determine failure modes and participate in, or makes recommendations for, corrective actions
• Participate in the investigation and resolution of customer complaints
• Support timely completion of all Corrective and Preventative Actions
• Collaborate with Engineers and Suppliers to ensure conforming product
• Support process validation program and associated activities
• Support Quality Control group as required
• Establish, measure and report quality assurance metrics
• Participate in Management Review responsibilities
• Ensure that standards and safety regulations are observed
• Actively seek out ways to drive process improvements and reduce QC requirements
• Participate in internal auditing activities
• Complete quality assurance improvement projects
• Maintain regulatory compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies
• Other duties as requested

Supervisory Responsibilities:

• None

Qualifications:

• Self-motivated, and results driven
• Strong analytical and problem-solving abilities
• Exceptional prioritization and organizational skills
• Familiarity with ISO 13485 or similar Quality Management standards
• Experience with Quality System Documentation and good manufacturing practices
• Excellent documentation skills including a comprehension of document traceability
• Ability to multi-task and adapt to a fast pace changing environment
• Ability to independently manage and document projects
• Working knowledge of tools, methods, and concepts of quality assurance
• Basic knowledge of relevant regulatory standards
• Excellent data collection, mathematical and data analysis skills
• A detail-oriented individual, with a “can do” attitude, and the ability to work in a team environment, as well as individually

• Education and/or Experience:
• Associates Degree in a related field
• 5 years of progressive, professional Quality Assurance experience OR an equivalent combination of education and experience
• Certificate in Quality Assurance is a plus

• Language Skills:
• Excellent written and verbal communication skills required to seamlessly collaborate across multifunctional groups

• Computer Skills:

• Proficient with Microsoft Office Suite primarily with Excel, Word, and PowerPoint
• Ability to evaluate and present data in a graphical format

• Physical Demands:

• Must be highly safety conscious
• Ability to lift up to 50 pounds
• Appropriate personal protection equipment and environmental control clothing must be worn where required

• Work Environment:

• Work performed in a manufacturing environment
• Approximately 50% sitting and 50% standing or walking
• May work at different workstations as quality needs arise

• Travel Requirements:

• Minimal