Sr. Quality Systems Engineer - CAPA

Description

Role expectations

• Lead and manage the CAPA process, including investigation, root cause analysis, and implementation of corrective and preventive actions.
• Collaborate with cross-functional teams to identify and resolve quality issues.
• Develop and maintain CAPA documentation, ensuring accuracy and compliance with regulatory standards.
• Partner with global teams to provide an independent, technical review of CAPAs 
• Monitor the effectiveness of CAPA actions and make necessary adjustments to ensure continuous improvement.
• Conduct regular CAPA reviews and audits to ensure compliance and effectiveness.
• Provide training and support to team members on CAPA processes and best practices.
• Prepare and present CAPA reports to management and regulatory bodies as required.
• Stay updated on industry regulations and standards related to CAPA and quality management.
• Report on status of CAPA system in alignment with site and corporate KPI’s 
• Support harmonization of QMS elements following Global initiatives and incorporation of systems. 
• Lead and support ongoing Quality Improvement projects and initiatives. 

What we're looking for

• Bachelor’s degree required
• Quality professional with minimum 8 years of experience - advantage in medical device industry 
• At least 4 years of direct CAPA experience, owning CAPAs, performing, root cause analysis using a variety of problem solving methodologies, and ideally performing CAPA training.
• Experience in medical device and knowledge in ISO13485 & 21 CFR Part 820  
• Ability to organize information effectively, prioritizing tasks according to their urgency and importance. 
• Ability to operate efficiently and effectively in a fast-paced environment 
• Ability to work independently and lead end to end activities 
• Strong written and verbal communication skills and teamwork skills 
• Proficiency in Arena is an advantage 
• Fluent in English, spoken and written

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.