Sr. Quality Systems & Compliance Engineer

Job Description

Job Description

Description

We are seeking a Sr. Quality Systems professional to support and continuously improve the effectiveness of the Quality Management System (QMS) within a regulated medical device environment.

This role requires broad QMS experience, strong independent judgment, and the ability to lead cross-functional initiatives with minimal direction. The successful candidate will work across multiple quality system processes to support compliance, improve effectiveness, drive continuous improvement, and strengthen overall QMS performance. The successful candidate will be intellectually curious, bring a continuous improvement mindset, proactively seek better ways of working, and embrace new technologies and tools to improve quality system effectiveness.

The ideal candidate understands how quality system elements interact, can identify risks and opportunities, and is capable of driving practical solutions across a diverse business. This role is primarily focused on site-level QMS effectiveness while participating in multi-site and global quality system initiatives as needed.

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

Education: Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.

Experience: 

• 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.

Skills:

• 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.

Complementary Skills:

• 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

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:

• 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.