Manager, Quality Systems

Orth Align, Inc., a growing medical device company, has an immediate opening for a Manager, Quality Systems who serves as Management Representative, providing leadership and implementation of the site quality objectives. This role is responsible for managing the entire quality system to ensure efficient and effective compliance with the Company Quality Policy and global quality management system requirements, while aligning with company objectives.

The Management Representative reports directly to the CEO.

• Oversee the quality management system functions including CAPA, change management, audits, training, and complaint handling, manage employees within these groups, identify and drive continuous improvement opportunities, publish and monitor analytical trends, and report performance of the QMS to top management.
• Provide quality leadership and direction to the organization, maintain and improve QMS documentation (policies and procedures), and conduct ongoing training on the QMS elements to ensure consistent application.
• Serve as Orth Align quality management representative, ensure that QMS requirements are established and documented, report performance and effectiveness of the QMS to top management, promote awareness of applicable requirements, and report items identified for escalation to management review.
• Lead audit and inspection preparation, resolve audit and inspection findings, liaise with auditing groups and inspectors throughout all states of the audits, provide guidance in interpreting global regulations and standards, and regularly communicate and educate the organization on regulatory expectations.

• BS/BA degree, 5+ years of experience in medical device quality management, or 8+ years of experience without a degree.
• Demonstrated performance leading teams to achieve goals and objectives, with the ability to lead through ambiguity and changing priorities.
• Expertise interpreting and applying ISO 13485, 21 CFR Part 820, ISO 14971, MDSAP, and European MDR.
• Strong proficiency using MS Office Suite (Word, Excel, PowerPoint) and PDF software.
• Excellent written, verbal, and presentation skills.
• Self‑motivated with the ability to work collaboratively as a team member and independently.
• Excellent attention to detail, producing high quality output.
• Flexibility and strong organizational skills with the ability to prioritize multiple tasks.
• Sound judgment when making decisions and communicating with internal and external customers.
• Experience managing all aspects of employee performance.
• Experience using an electronic quality management system for product lifecycle and change management.
• Strong interpersonal relationship skills including negotiation and relationship management.
• ISO 13485 Lead Auditor certification.
• ASQ CQA and/or CMDA, CQE and Quality Manager certification (preferred).

• Competitive compensation including bonus and equity.
• Opportunities for career advancement.
• Full benefits package.
• An evolving, engaging culture and workplace.
• Top Place to Work in Orange County.

It's an exciting time at Orth Align - make your next career move with us!