PRIMARY DUTIES AND RESPONSIBILITIES
• Serve as the management representative of the company’s quality systems with direct engagement in all company processes, process improvements, and quality issues or quality related concerns.
• Promote quality excellence and performance improvement throughout the company.
• Develop, implement, communicate and maintain a company-wide quality plan to position the company’s quality systems and policies in alignment and compliance with national and international quality standards.
• Establish and maintain a liaison with customer’s quality representatives ensuring the execution of corrective action and compliance with customer’s specifications.
• Responsible for the oversight and auditing of all company safety programs and processes for compliance with company, state, and federal requirements.
• Maintain key ISO quality registrations.
• Meet quality objectives as defined in business’ balanced scorecards.
SECONDARY DUTIES AND RESPONSIBILITIES
• Effectively interact with Operations and Engineering teams to maintain reliable production and in the development of new products.
• Interact with the purchasing staff to establish quality requirement for external suppliers.
• Identify relevant quality related training requirements and deliver or direct required training.
• Define quality procedures in conjunction with the operations staff.
• Monitor the efficacy of company’s quality systems by gathering relevant data and producing statistical based reports.
• Collate and analyze company quality performance data and charts against defined parameters.
• Review appropriate standards and assist in establishing clearly defined quality methods for operations management to apply.
• Prepare, maintain and present APQP documentation as required.
• Responsible for all corporate quality reports and records.
Responsible for the direction, training, and development of quality system functions with the company’s manufacturing locations.
Minimum of Bachelor’s Degree in applied science or engineering field.
Five years prior experience in Quality Assurance for a manufacturing organization with emphasis on root cause analysis and corrective action, continuous improvement, six-sigma tools, and process validation.
Trained and qualified in quality system audits and quality management systems.
Experience in a FDA compliant quality system related to medical device manufacturing is highly desirable.
QSR/CGMP knowledge, auditing experience, design of experiments, six sigma certification, and knowledge of lean manufacturing are desirable.
• Superb listening skills and ability to probe for understanding.
• Excellent written and verbal communication skills with a varied audience.
• Credible technical, business, and manufacturing knowledge.
• Versatile technical skills for review of electrical, mechanical, graphical, and software designs.
• Problem solving aptitude to accurately define, analyze, break down, and solve complex problems.
• Proficiency in Microsoft Office and Project software.
• A quick learner.
• Driving desire for personal and organizational improvement.
• Unquenchable thirst for operational excellence.
• Desire to own decisions and take responsibility for outcomes.
• Willingness to travel when required.