Quality Engineering and Control Manager

Responsible for evaluating, establishing and implementing quality requirements for products and

processes used to manufacture Zest Dental Solutions devices, existing and in development. Additional responsibility can include maintenance of all inspection requirements, inspection programs, and inspection equipment. As well, manage and ensure the effective day-to-day operations of Quality Control by organizing priorities, providing instructions, and resolving problems.

Essential

Job Duties and Responsibilities:

• Manage the Quality Engineering department, ensuring product quality and operational goals are met.
• Initiate and implement programs and process controls aimed at improving the quality of operations and reducing the total cost of manufacturing.
• Responsible for the acquisition, maintenance, and disposal of all company measurement devices, gages, and equipment.
• Provide support for new product development projects. This includes drawing reviews, product and process risk assessments, and validation execution.
• Develop quality plans, inspection processes, and sampling procedures. This includes validation of inspection methods and equipment as required.
• Provide oversight for programming of complex automated inspection equipment.
• Support Quality Control and Complaints department by performing product evaluations for the most complex or unclear product discrepancies.
• Perform tracking and trending of nonconforming products, complaints, efficiencies, and other key metrics.
• Manage the calibration department, ensuring the company is always in compliance with the calibration program and responsibility for properly conducting calibration of gages, either in house or through external suppliers.
• Provide support for onboarding and evaluation of suppliers, including participation on the supplier review board and conducting supplier audits.
• Establish work priorities for Quality Control that are in line and supportive of the requirements of operational goals.
• Train Quality Control personnel in product characteristics, attributes and quality control procedures, ensuring that personnel are trained appropriately to perform the tasks assigned and commensurate with their job descriptions.
• Participate in support of audits representing key functional areas of responsibility as well as general support during the audit process. Audits may be from external regulatory bodies, Zest customers, or external consultants.
• Job duties are not limited to the areas of responsibility listed above. Specific responsibilities may be modified, and additional responsibilities may be assigned which are in line with the job summary at the discretion of company management.

Education, Experience, Skills, & Abilities:

• Minimum 8-10 years of related experience in medical device or other FDA regulated industry.
• Operational experience in a fast-paced, high volume operation.
• Ability to work extensively in all MS Office programs, Adobe, ERP systems.
• Excellent and highly disciplined organizational, time-management, and follow-up skills are required.
• Self-starting leader with proven ability to drive toward excellent quality, service and support of corporate goals.
• Excellent written, presentation and oral communication skills.
• Ability to demonstrate a high standard for accountability, work ethic and dedication to tasks and assignments.
• Knowledgeable in the implementation, support and administration of document controls systems.
• Must have experience working with end users and/or customers in a professional capacity.
• Solid organizational and planning skills with the ability to plan and organize workload to ensure the efficient use of limited time and resources.
• Prioritizing own work to effectively achieve objectives and standards.
• Basic problem solving and investigation skills; basic critical thinking skills.