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.

• 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.

• Bachelor’s degree in Engineering, Quality, Information Technology, Industrial Engineering or a related field.
• 4-6 years experience working with QMS and electronic QMS tools within the medical device industry. Experience with Arena PLM is considered an advantage.
• Practical expertise with platforms such as Arena (preferred) and Agile, and strong technical knowledge of QMS electronic tools.
• Solid understanding of regulatory requirements including ISO 13485, FDA 21 CFR Part 820, MDSAP, and EU MDR.
• Proven experience creating and updating procedures, leading CAPA investigations, performing root cause analysis and training others on quality processes.
• Excellent presentation and communication skills, with a track record of working effectively with cross-regional stakeholders.
• Ability to work independently and collaborate with global teams and colleagues from diverse backgrounds and cultures, showing respect, adaptability, and a commitment to building a strong quality culture.

Complementary skills:

• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint).
• Ability to work flexible hours to support collaboration across APAC, EMEA, and Americas regions.
• Creative thinking to make quality engaging for everyone and inspire a culture where every team member is a champion for quality.

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.

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:

• Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment
• Back-up Child/Elder Care and access to a caregiving concierge
• Family Forming Benefits – Available to Employees, and their spouse or domestic partner, covered under one of Align’s health plans
• Breast Milk Delivery and Lactation Support Services
• Employee Assistance Program
• Hinge Health Virtual Physical Therapy – Available to all employees and eligible dependents (age 18+) enrolled in an Align medical Plan

Employee benefits. Align offers its employees:

• Short-term and long-term disability insurance in accordance with those plans.
• Basic Life Insurance and Accidental Death and Dismemberment. Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans.
• Flexible Spending Accounts – Employees may be eligible to participate in a health care account (including a limited health FSA if enrolled in a HDHP), dependent care account, and a pre-tax commuter benefit plan.
• 401k plan (with a discretionary Company match of 50% up to 6% of eligible earnings up to a maximum match of 3%.). Employer match vests after two years – 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
• Employee Stock Purchase Program (Employees must work 20 hours or more and be employed on purchase date to be eligible).
• Paid vacation of up to 17 days during the first full year of employment (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days. Annual paid vacation time accrual increases based on tenure. Both exempt and non-exempt employees who work 32 hours or more per week receive prorated vacation accrual based on their regularly scheduled work hours and tenure.
• Sick time is accrued throughout the year at the rate of one hour for every thirty worked. Employees can carry over unused sick leave each year, up to a maximum balance of 80 hours.
• 11 Company-designated paid holidays throughout the year.
• If employed for at least 12 consecutive months, Align will grant up to 6 weeks of paid Parental Leave. If employed for less than 12 consecutive months, Align will grant up to 4 weeks of paid Parental Leave. All parental leave must be completed within one year of the birth or placement of the child. Parental leave is in addition to any state and/or local parental leave benefits. Three days of paid bereavement leave. In some cases, due to travel the amount of paid leave may be extended to 5 paid days off. To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
• Non-exempt employees will receive full pay for up to 10 days of jury duty. Exempt employees will receive their full salary during any week they serve and perform any work. Other insurance such as legal, critical illness, voluntary accident, long-term care, auto, home and pet insurance are available for purchase.

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