Sr. Quality Systems & Compliance Engineer

Role expectations

• Lead and support key Quality Management System (QMS) processes.
• Drive continuous improvement initiatives that enhance QMS effectiveness and compliance.
• Support activities across CAPA, Nonconformance Management, Internal Audits, Management Review, Document Control, and Training.
• Analyze quality system performance data and identify opportunities for improvement.
• Author and maintain procedures, work instructions, forms, and quality system documentation.
• Provide quality systems guidance, coaching, and support to cross-functional stakeholders.
• Partner with Engineering, Manufacturing, Operations, Regulatory Affairs, and Quality teams to improve process effectiveness and business performance.
• Support site audits, inspection readiness activities, and resolution of quality system issues.
• Participate in multi-site and global quality system initiatives, harmonization efforts, and process improvement projects.

What we're looking for

• Typically 6–10 years of experience in Quality Systems, Quality Engineering, Compliance, or related quality disciplines within the medical device industry. 
• Broad experience across multiple QMS processes and quality disciplines.
• Experience conducting internal audits and supporting external audits or regulatory inspections. 
• Demonstrated ability to lead cross-functional initiatives and drive actions to completion.
• Experience working within multi-site quality systems preferred.

• Strong understanding of Quality Management System principles and practices.
• Knowledge of medical device quality system requirements and industry standards.
• Strong problem-solving, root cause analysis, and risk-based decision-making skills.
• Ability to understand how quality system processes interact and impact overall business performance.
• Ability to work independently, navigate ambiguity, and lead initiatives with minimal direction.
• Leverages data, digital technologies, and emerging tools, including AI-enabled solutions, to drive efficiency and effectiveness.
• Strong communication, collaboration, and influencing skills. Ability to communicate and influence across all levels of the organization.
• Excellent organizational and project management capabilities.
• Ability to mentor and guide teams in quality system compliance and continuous improvement practices.

• ISO 13485 Lead Auditor certification, ASQ Certified Quality Auditor (CQA), or equivalent auditor qualification. 
• Experience hosting FDA, Notified Body, MDSAP, or ISO 13485 audits. 
• Experience with electronic Quality Management Systems (eQMS) such as Arena or equivalent. 
• Knowledge of risk management methodologies such as ISO 14971, PFMEA, or FTA. 
• Lean, Six Sigma, or other continuous improvement training/certification.

Pay Transparency

• 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

• 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.  

About
Your growth and well-being:At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:Health and well-being programs to keep you thriving in both body and mind.Employee-exclusive discounts on Invisalign products.Learning opportunities through online learning resources and support for your individual development plans.Inclusive, global workplace that fosters collaboration, recognition and belonging.Country and/or role specific details will be shared with you by your recruiter during the interview process. Discover Align:We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time. As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.Eager to learn how we embrace our global differences and nurture employee well-being? Explore Align's culture here!Want to discover more about exocad and Cubicure? Click on their names for additional information.