Director of Quality and Regulatory Affairs

Position: Director of Quality and Regulatory Affairs, reporting to the CEO of Turner Innovations.

Location: Primary work location is in Orem, Utah, although it is expected that occasional work from home may be possible. Relocation is not available.

Essential Job Duties:

· Serve as the Quality Management Representative for Turner entities in accordance with applicable quality system requirements, including ISO 13485 and 21 CFR 820.

· Ensure quality management system processes are documented, effective, and communicated throughout the organization.

· Report to top management on QMS effectiveness, regulatory compliance, and opportunities for improvement.

· Serve as the Person Responsible for Regulatory Compliance under EU MDR, as applicable, ensuring device conformity, technical documentation, post-market surveillance, and regulatory reporting obligations are maintained.

· Oversee all aspects of the organization’s total quality function, including quality policies, programs, initiatives, and continuous improvement activities.

· Act as liaison for notified bodies and certification partners for QMS certifications, product certifications, and related regulatory activities.

· Manage internal and external audits, including planning, execution, follow-up, and corrective action oversight.

· Oversee document control functions for the company and subsidiaries.

· Train team members on the QMS system, regulatory requirements, and their respective quality responsibilities.

· Perform quality engineering tasks to support product development, manufacturing, process needs, and finished medical products or service cases.

· Perform receiving, in-process, final inspection, quality assurance, and quality control activities as needed.

· Prepare technical writing, reports, data analysis, and quality tools such as fishbone diagrams, 5 Whys, Pareto analysis, and related methods.

· Lead and direct the work of others as needed.

· Perform other tasks as assigned by the CEO.

Qualifications and Competency Requirements:

· Bachelor of Science degree or higher in engineering, sciences, or another technical field preferred; minimum Associate Degree or equivalent education and experience required.

· Minimum of 10 years of experience in quality management, including establishing and maintaining quality system elements related to product development and manufacturing medical products.

· Experience with quality system audits and regulatory compliance processes involving regulatory bodies and standards.

· Working knowledge of standards and guidance for medical device development and manufacturing, including FDA and EU medical device regulations.

· Experience with document control, including product lifecycle management software.

· American Society for Quality certification preferred but not required.

· Regulatory Affairs Certification in medical devices preferred.

· Project Management Professional certification preferred.

Skills and Abilities:

· Process-oriented with the ability to drive tasks to completion.

· Strong reasoning skills to define problems, interpret data, establish facts, and draw valid conclusions.

· Technical ability to propose, coordinate, and direct activities that verify product compliance, performance, quality, and robustness.

· Principle-centered leadership qualities with the ability to lead teams across departments.

· Strong interpersonal skills and ability to work constructively and cooperatively with all departments.

· Ability to effectively communicate, motivate people in a positive and constructive manner, and influence a proactive company culture.

· Confidence in making presentations and resolving conflict.

· Strong organizational skills with the ability to manage multiple tasks, prioritize workflow, work independently, and complete a significant volume of work.

Benefits:

• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person