Sr. Quality Management Systems Engineer

Job Description

Job Description

Description

This position is ideal for experienced quality professionals to join the Quality Management team as a Sr. Quality Management Systems (QMS) Engineer, leading quality system integration and compliance efforts. Partnering with cross-functional and global teams, you’ll provide strategic direction and hands-on support for implementing and maintaining compliant Quality Management Systems. This role is vital in ensuring regulatory compliance and continuous improvement across Align Technology’s operations.

Role expectations

• Conduct gap assessments on remote site Quality Management Systems
• Develop and maintain Quality plans for the integration of new entities into the Align QMS
• Drive QMS integration activities
• Assist in onboarding entities as subcontractors and internal suppliers under Align QMS and support development of Quality Agreements
• Assist in implementation of quality initiatives and corporate policies at the site
• Guide functional and cross-functional teams in defining core quality system processes
• Assist in maintaining ISO 13485 : 2016, EU MDD / MDR, FDA 21 CFR Part 820 compliant QMS
• Conduct Quality Systems audits and provide training / guidance to other auditors
• Assist with preparation and hosting of external Quality System inspections
• Perform other duties as assigned

What we're looking for

Pay Transparency

If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.

For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.

Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.