Global QMS Engineer

Overview Department: Quality | Location: US‑North Carolina‑Raleigh This position is ideal for experienced professionals with strong QMS knowledge who want to make a global impact. As a Global QMS Engineer, you'll join a dynamic team working across regions — including North America, EMEA, APAC and LATAM. You will play a key role in shaping Align's Quality Management System by supporting the design, implementation, and continuous improvement of harmonized global QMS processes. Partnering with regional QA leads and cross‑functional teams, you'll help establish consistent, agile, and audit‑ready quality processes that support business growth and ensure alignment with regulatory requirements and leadership expectations. This role also offers the opportunity to explore and support emerging technologies and electronic QMS tools as part of the team's digital transformation journey. Responsibilities Design and deploy global QMS processes by collaborating with process owners and regional QA & RA leads. Partner with eQMS administrators (e.g., EDMS, LMS) to translate process needs into system configuration requirements and support rollout of new workflows and tools. Integrate new business entities (e.g., acquisitions, new sites) into global QMS processes and electronic quality tools, from readiness assessment through system configuration and adoption. Ensure ongoing effectiveness and compliance of global QMS processes in collaboration with regional QA & RA leads; maintain documentation (SOPs, WIs, templates) with clarity, traceability, and audit readiness; train and mentor regional teams on updated processes and procedures. Support global CAPA and NC processes including investigations, root‑cause analysis, corrective/preventive actions and effectiveness verification. Monitor, analyze, and present quality KPIs for management reviews and global forums; leverage data trends to drive continuous improvement. Support internal and external audit readiness; contribute to standards assessment and gap analysis (ISO 13485, FDA QMSR, EU MDR, MDSAP). Participate in global QMS forums to promote alignment and knowledge sharing. Participate in the evaluation and adoption of emerging technologies (e.g., AI‑enabled solutions, automation tools) to enhance QMS efficiency, data insights, and user experience. Qualifications Bachelor's degree in Engineering, Science, Quality, Information Technology, Industrial Engineering, or a related field. 4–6 years of experience in QMS in the medical device industry. Strong understanding of ISO 13485, FDA QMSR/QSR, EU MDR, MDSAP, and global regulatory landscapes. Hands‑on expertise across key QMS areas: procedure creation and updates, CAPA investigations, root‑cause analysis, and training teams on quality processes. Experience with electronic QMS tools (e.g., Arena PLM, Agile, Veeva, MasterControl or similar) and/or LMS platforms (e.g., Docebo, Cornerstone). Experience with Business Intelligence tools (e.g., Power BI, Tableau) for quality data analysis and reporting — an advantage. 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 from diverse backgrounds and cultures. Proficiency in English is mandatory. 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. Pay Transparency If provided, the 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. Benefits 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 include: 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) available for purchase. 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. 401(k) 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 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. Paid Parental Leave: if employed for at least 12 consecutive months, up to 6 weeks; if less, up to 4 weeks. 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. Equal Opportunity Statement Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire. #J-18808-Ljbffr Align Technology