Manager, Quality Systems

OrthAlign, Inc., a Smart Technologies, 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, global quality management system requirements, as well as alignment with company objectives. This position requires a results-oriented hands-on leader who is responsible for the health of the quality system including management review, audits, complaint handling, CAPA, training, document control, and change control. This position liaisons with Product Quality and Operations to ensure product quality issues are addressed in a timely and effective manner, and in a manner aligned with the OrthAlign Quality Policy and the quality management system. The Management Representative has a dotted reporting line to the CEO.

You will:

• Oversee the quality management system managing the QMS functions including CAPA, change management, audits, training, and complaint handling. This includes managing the employees within these groups, identifying, and driving continuous improvement opportunities, publishing and monitoring analytical trends. As the management representative for quality, the job functions include ensuring that quality management system requirements are effectively established and maintained, reporting to top management on the performance of the quality management system and ensuring the promotion and awareness of regulatory requirements throughout the organization.
• Provide quality leadership and direction to the organization to ensure efficiency of processes and the eQMS system. This includes maintaining and improving quality management system documentation i.e. policies and procedures to ensure ongoing compliance with quality system standards and requirements as well as current company and industry practices. This includes ongoing training on the elements of the QMS within the organization to ensure understanding and consistent, effective application.
• Serve as the OrthAlign quality management representative. Ensure the processes needed for the quality management system (QMS) requirements are effectively established and documented, report on the performance and effectiveness of the QMS to top management, ensure the promotion of awareness of applicable requirements throughout the organization, and ensure that items identified for escalation to management review are reported to top management.
• Lead audit and inspection preparation, present resolution of audit and inspection findings, and liaise with auditing groups and inspectors through all states of the audits. Provide guidance in interpreting global regulations and standards; regularly communicate and educate the organization on these regulatory expectations.

You need:

• Your BS/BA degree, 5+ years of experience, or without degree and 8+ years, in medical device quality management
• Demonstrated performance leading teams to achieve goals and objectives, with ability to lead through ambiguity and changing priorities
• Demonstrated expertise interpreting and applying all aspects of ISO 13485, 21 CFR Part 820, and ISO 14971, as well as familiarity with MDSAP, and the European MDR
• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint) and PDF software
• Demonstrates excellent written, verbal, and presentation skills
• Self-motivated with the ability to work as a collaborative team member as well as independently
• Excellent attention to detail, producing high quality output
• Flexibility and strong organizational skills with ability to prioritize multiple tasks
• Applies 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 negotiating and relationship management
• ISO 13485 Lead Auditor certification
• ASQ CQA and/or CMDA, CQE and Quality Manager certification (preferred)

We offer:

• Competitive compensation including bonus and equity
• Opportunities for career advancement
• Full benefits package
• An evolving, engaging culture and workplace
• Nominated by our employees as a Top Place to Work in Orange County!

It is an exciting time at OrthAlign - make your next career move with us!

Please note that we are unable to provide any type of sponsorship at this time.

No recruiters, please.