Quality Director

SUMMARY OF ROLE

The Quality Director controls, plans, directs, monitors, and organizes the quality assurance activities to ensure that the SARS-CoV2 test kits are manufactured in accordance with policies and procedures to produce devices that meet specifications and satisfy customers. Primary duties are focused on the Quality Management system and leadership of the quality team within the scope of 21 CFR Part 820, ISO13485:2016, and ISO 9001:2015. Position will provide leadership and promote a quality culture within the organization.

TYPE: Full Time

LOCATION: Ogden, Utah

THIS ROLE WILL REPORT TO: Vice President of Quality and Regulatory

RESPONSIBILITIES:

• Develops, establishes, and maintains quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure customer satisfaction.
• Act as the Quality Systems Management Representative for the site.
• Maintain compliance and effectiveness to Quality Management System.
• Represents the business/site to outside customer audits. Facilitates (with the VP of Quality/RA) any regulatory audits.
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance, and then assist the organization in driving implementation.
• Develops and directs quality programs involving methods, devices, and controls.
• Maintains quality through internal and external inspection of raw materials and finished items purchased and production operations and processes.
• Supporting the development, implementation, and continuous improvement of current and future Quality Management Systems
• Responsible for managing CAPA system.
• Flexibility in resolving issues while maintaining compliance.
• Develop quality objectives and lead efforts related to the companys quality vision.

PREFERRED EXPERIENCE:

• Proven experience as Quality Director or Manager with broad responsibility.
• Experience in the Medical Device industry.
• Proficient at data analysis.
• In depth understanding of quality control and regulatory standards.
• Certification as ASQ CQA/CQE/CQM is preferred (ISO 13485, MDSAP, EUMDR, etc.)
• Lean Six Sigma Black Belt is preferred, Green Belt or similar experience will be considered
• Quality Management: 5 years (Preferred)
• ISO13485/MDSAP/EUMDRCertified: 10 years (Preferred)
• Quality assurance: 10 years (Preferred)
• Experience with FDA/Health Canada/International Regulatory bodiesor government agencies helpful