Compliance Section Manager

Overview

At Ortho Development, we help people do what they love by restoring mobility through innovative orthopedic hip and knee solutions. From our headquarters in Draper, Utah, we’re proud to provide meaningful work with a strong, collaborative culture where every team member can make a difference. Here, you’ll find teammates who care, leadership that listens, and opportunities to learn, grow, and succeed.

We offer competitive benefits and a workplace environment designed to help you thrive and promote work-life balance.

Compliance Section Manager is responsible for overseeing all activities related to internal and external audits, supplier quality compliance, and standards gap assessments. This role ensures the Quality Management System (QMS) remains compliant with ISO 13485, FDA 21 CFR Part 820, MDSAP, and applicable international regulations. It provides leadership for supplier compliance, audit readiness, and continuous improvement activities to maintain regulatory alignment and product quality.

This is a full-time onsite position available to start immediately.

Location: Onsite - Draper, UT

Schedule: Monday - Friday

• Lead and manage the Internal and External Audit Programs in compliance with applicable procedures and standards.
• Develop and maintain the annual audit schedule; ensure timely completion and closure of audit findings.
• Oversee supplier compliance processes, including qualification, performance evaluation, and supplier audits.
• Provide oversight for the Control of Standards process, ensuring Quality performs timely and effective gap analyses of critical standards and implements resulting QMS updates as required.
• Ensure ongoing monitoring of regulatory and standards updates, coordinating Quality’s input to maintain compliance across global markets and new-market entries.
• Supervise the Compliance Coordinator and Supplier Compliance Engineer, providing guidance and direction to achieve departmental objectives.
• Review and approve supplier audit reports, audit responses, and compliance documentation.
• Monitor supplier corrective actions and performance trends; escalate recurring issues as needed.
• Support CAPA, Risk Management, and Management Review inputs related to compliance metrics.
• Act as the primary liaison for external auditors, regulatory agencies, and supplier quality representatives.
• Develop and present compliance reports and trend analyses for QSMR and management review.
• Serve as a trained backup Internal Auditor for QMS audits, supporting audit planning, execution, and follow-up.
• Drive continuous improvement initiatives to enhance the maturity and effectiveness of the QMS.
• Collaborate with other QA Section Managers to ensure consistent application of Quality System requirements across all areas.
• Perform other job-related duties as assigned.

• Bachelor's degree in Engineering, Life Sciences, Quality Systems, or Regulatory Affairs
• Master’s degree in Quality Management or Engineering – (Preferred)
• ISO 13485:2016 Lead Auditor Certification
• Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) or Similar
• Regulatory Affairs Certification (RAC) – (Preferred)
• Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt (CSSGB/CSSBB) – (Preferred)
• Specific training courses in this field:

• ISO 13485:2016 Lead Auditor or Internal Auditor Training
• FDA 21 CFR Part 820 / QSR Training
• MDSAP Awareness and Application – (Preferred)
• Supplier Quality Management and Auditing Techniques
• CAPA and Risk Management Processes
• Root Cause Analysis and Problem Solving Tools – (Preferred)
• Japan and Brazil Regulatory Requirements Awareness (PMDA / ANVISA) – (Preferred)

• Minimum 7 years of experience in Quality Systems or Regulatory Compliance within a medical device or similarly regulated industry
• Minimum 3 years in a lead or supervisory role managing audits, supplier quality, or QMS compliance activities
• Demonstrated experience leading external audits (Notified Body, FDA, ISO Registrar) and managing supplier audit programs
• Proven ability to perform gap assessments and drive system-level improvements
• Experience with eQMS tools such as Master Control or similar platforms – (Preferred)

• Strong leadership and team mentoring abilities
• Excellent verbal and written communication skills
• Strong analytical, organizational, and time management skills
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook)
• Ability to interpret and apply regulatory requirements to practical quality system improvements
• Cross-functional collaboration and presentation skills – (Preferred)

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discounts
• Flexible spending account
• Health insurance
• Life insurance
• Paid Holidays
• Paid time off
• Parental leave
• Tuition reimbursement
• Vision insurance
• Wellness incentives
• UTA Transit Pass