QMS Project Manager

Department: Quality

Location: US-North Carolina-Raleigh

Description

This position is ideal for experienced professionals with strong QMS and Project Management expertise to join the Invisalign Multi-Site QMS team as a QMS Project Manager. You will support the harmonization of quality processes across sites, identify and implement opportunities for continuous improvement, and enable data-driven decision-making. The position will collaborate with multiple stakeholders across the organization, including operations quality leaders, regulatory affairs, operations, and product development to achieve organizational goals and foster a culture of quality.

Role expectations

• Lead QMS continuous improvement projects to increase efficiency of the QMS and drive organization compliance
• Facilitate cross-functional improvement projects that enhance QMS processes, reduce waste, and promote best practices.
• Lead the development, implementation, and continuous improvement of the QMS to ensure compliance with applicable regulatory requirements and relevant international standards (e.g., ISO 13485, MDSAP, EU MDR, FDA QSR/QMSR, etc.).
• Monitor, analyze, and report on QMS effectiveness and compliance metrics through management review.
• Manage Internal Audit Program and ensure there is adequate resourcing to conduct audits.
• Ensure the QMS and business are in a state of audit readiness.
• Serve as a point of contact for external audits and regulatory inspections; support responses to audit observations and ensure effective corrective actions.
• Champion digital transformation initiatives (as applicable) to enhance quality process efficiencies.
• Provide guidance on Standard Operating Procedures (SOPs), work instructions and other QMS documents.
• Provide training and mentorship for quality processes.
• Promote a strong quality culture across the organization.
• Stay abreast with evolving regulatory requirements, standards, and best practices.
• Interpret and communicate regulatory changes to internal stakeholders and ensure timely updates to quality processes and documentation.
  
  

What We're Looking For

• Education: Bachelor’s degree in Engineering, Quality, or a related field; advanced degree preferred.
• Experience: Minimum of 6-8 years of experience.
  
  

Skills

• In-depth knowledge of ISO 13485, FDA QSR, MDSAP, and EU MDR requirements.
• Experience in project or program management
• Interest or experience in QMS technology applications and AI to improve efficiency and compliance preferred
• Communication: Strong leadership, communication, and interpersonal skills.
• Teamwork: Ability to work effectively in a cross-functional team environment.
  
  

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.

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. 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.

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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.