Ortho Development Corporation · 6 days ago
Compliance Section Manager
Draper, UT
Full-time
Onsite
Senior Level
7+ years expOrtho Development Corporation is dedicated to restoring mobility through innovative orthopedic solutions. The Compliance Section Manager will oversee internal and external audits, supplier quality compliance, and ensure the Quality Management System remains compliant with relevant regulations.
3D PrintingHealth CareManufacturingMedical
Responsibilities
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
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, Quality Systems, or Regulatory Affairs
ISO 13485:2016 Lead Auditor Certification
Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) or Similar
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
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
Preferred
Master's degree in Quality Management or Engineering
Regulatory Affairs Certification (RAC)
Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt (CSSGB/CSSBB)
MDSAP Awareness and Application
Root Cause Analysis and Problem Solving Tools
Japan and Brazil Regulatory Requirements Awareness (PMDA / ANVISA)
Experience with eQMS tools such as MasterControl or similar platforms
Cross-functional collaboration and presentation skills
Benefits
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
Company
Ortho Development Corporation
Ortho Development Corporation is a manufacturing company that designs orthopedic devices.
51-200 employees
H1B Sponsorship
Ortho Development Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
H
Hiroyuki Minamiya
CEO
Greg Larson
President
Recent News
2025-08-26
Company data provided by crunchbase