QMS & PLM Engineer

Job Description

Job Description

Description

This position is ideal for experienced professionals with strong QMS and PLM expertise to join the Global QMS team as a QMS and PLM Engineer. You will support the harmonization of quality processes across regions, optimize system configurations and enable data-driven decision-making. Partnering with cross-functional teams to ensure our global QMS is not only compliant but also agile, scalable, and digitally empowered to ensure alignment with corporate standards and support regulatory readiness across the organization. This role helps create standardized and consistent quality processes within Align QMS, supporting the success of the business.

Role expectations

• Develop and maintain workflows, templates, access permissions, and system documentation to support QMS areas including, but not limited to, Change Management, CAPA, NC, Internal Audits, using QMS electronic tool (e.g. Arena).
• Manage user roles and system functionality to support quality processes across the organization.
• Contribute to global harmonization by reviewing site-specific QMS procedures and aligning them with corporate standards.
• Create and maintain standardized documentation, procedures, and templates to ensure traceability and compliance with internal policies and external regulations.
• Support training efforts for QMS and PLM processes, and assist in change management activities, including communication and rollout of new or revised procedures.
• Collaborate with quality leads, process owners, and stakeholders across functions and geographies to ensure consistent implementation of QMS and PLM practices.
• Participate in internal audits and support external regulatory inspections by ensuring system readiness and data integrity.
• Support global CAPA and NC processes by investigating issues using root cause analysis techniques, developing effective corrective and preventive actions, monitoring implementation and verifying results.
• Improve and assess PLM system configurations (such as Arena, Agile or similar electronic QMS tool) to ensure alignment with global QMS processes.

What we're looking for

Complementary skills :

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.

General Description of All Benefits

We are pleased to provide a general description of the benefits Align offers to full-time employees in this position.

Family Benefits.  Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings),  dental, and vision in accordance with those plans.  Align also offers to employees :

Employee benefits.  Align offers its employees :

To the extent applicable state or local law offers more generous benefits, Align complies with any such law.