Director, Quality Systems
Align Technology, Morrisville, NC, United States
Description
We are seeking a dynamic and experienced Director, Quality Systems to lead the Invisalign QMS. The successful candidate will partner with Align Global QMS leaders to create a quality management infrastructure that is compliant, effective, efficient, agile, and that supports a rapidly growing business with complex and diverse product lines (both hardware and software).
S/he will play a crucial role in maintaining and enhancing our Quality Management System (QMS) to ensure compliance with all relevant regulations and standards, including FDA QMSR, ISO 13485, and other applicable international guidelines.
S/he will partner with cross‑functional teams across the organization to champion a culture of quality excellence, continuously improving our processes and procedures to guarantee patient safety and product effectiveness.
Responsibilities
Lead and manage the Invisalign Multi‑site QMS to ensure industry best practices and compliance with regulatory requirements.
Oversee the harmonization of quality system processes at various global sites included in the scope of the Invisalign quality system, including internal audits, document control, risk management, non‑conformance and corrective action handling, inspections, training, and management review.
Partner closely with the Align Global QMS team to implement corporate QMS policies and work toward a single, harmonized, global QMS for Align.
Serve as a technical expert in QMS best practices, staying abreast of evolving FDA regulations and international standards, providing guidance and interpretation to internal stakeholders.
Interface with regulatory agencies during inspections and pre‑market submissions, ensuring clear and timely communication on all quality‑related matters.
Foster a culture of quality consciousness throughout the organization, promoting awareness of regulatory requirements and best practices across all departments.
Develop and implement quality metrics and key performance indicators (KPIs) to monitor the effectiveness of the QMS and identify areas for improvement.
Lead and participate in various quality projects and initiatives, driving continuous improvement efforts within the organization.
Provide coaching and mentorship to quality staff, building and developing a high‑performing team.
Oversee QMS certification strategy for various Align locations and legal manufacturers.
Be single point of contact for communication with QMS certification bodies.
Effectively develop and deliver updates to executive management on a regular basis.
Possible travel: 15%
Qualifications
Master’s degree in Quality Management, Engineering, or a related field, or Bachelor’s degree with significant experience in a quality‑related role.
Minimum 12 years of experience in the medical device industry, with at least 8 years in a leadership position within a Quality Systems department.
Demonstrated expertise in FDA regulations, including QSRs, and relevant international standards, such as ISO 13485.
Expert understanding of Quality Management System principles and implementation methodologies.
Proven ability to build and lead high‑performing teams, fostering a collaborative and proactive work environment.
Excellent communication, interpersonal, and presentation skills.
Meticulous attention to detail and ability to manage multiple priorities effectively.
Strong analytical and problem‑solving skills with a data‑driven approach to quality improvement.
Hands‑on experience with both SaMD and hardware medical devices.
Working knowledge of project management tools and techniques is required.
Six Sigma, RAC, ASQ certification is preferred.
Lead auditor qualifications.
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.
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.
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.
Basic Life Insurance and Accidental Death and Dismemberment. Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) available for purchase in accordance with those plans.
Flexible Spending Accounts – Employees may be eligible to participate in a health care account, 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 (eligible after 20 hours or more of employment).
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.
Sick time is accrued throughout the year at the rate of one hour for every thirty worked hours. Unused sick leave can be carried over each year, up to a maximum balance of 80 hours.
11 company‑designated paid holidays throughout the year.
Paid parental leave up to 6 weeks for employees with at least 12 consecutive months of service (4 weeks if less than 12 months) and must be completed within one year of the birth or placement of the child.
Paid bereavement leave for three days.
Non‑exempt employees receive full pay for up to 10 days of jury duty. Exempt employees receive full salary during any week served.
Insurance options such as legal, critical illness, voluntary accident, long‑term care, auto, home and pet insurance are available for purchase.
Applicant Privacy Policy Review our Applicant Privacy Policy for additional information.
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.
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S/he will play a crucial role in maintaining and enhancing our Quality Management System (QMS) to ensure compliance with all relevant regulations and standards, including FDA QMSR, ISO 13485, and other applicable international guidelines.
S/he will partner with cross‑functional teams across the organization to champion a culture of quality excellence, continuously improving our processes and procedures to guarantee patient safety and product effectiveness.
Responsibilities
Lead and manage the Invisalign Multi‑site QMS to ensure industry best practices and compliance with regulatory requirements.
Oversee the harmonization of quality system processes at various global sites included in the scope of the Invisalign quality system, including internal audits, document control, risk management, non‑conformance and corrective action handling, inspections, training, and management review.
Partner closely with the Align Global QMS team to implement corporate QMS policies and work toward a single, harmonized, global QMS for Align.
Serve as a technical expert in QMS best practices, staying abreast of evolving FDA regulations and international standards, providing guidance and interpretation to internal stakeholders.
Interface with regulatory agencies during inspections and pre‑market submissions, ensuring clear and timely communication on all quality‑related matters.
Foster a culture of quality consciousness throughout the organization, promoting awareness of regulatory requirements and best practices across all departments.
Develop and implement quality metrics and key performance indicators (KPIs) to monitor the effectiveness of the QMS and identify areas for improvement.
Lead and participate in various quality projects and initiatives, driving continuous improvement efforts within the organization.
Provide coaching and mentorship to quality staff, building and developing a high‑performing team.
Oversee QMS certification strategy for various Align locations and legal manufacturers.
Be single point of contact for communication with QMS certification bodies.
Effectively develop and deliver updates to executive management on a regular basis.
Possible travel: 15%
Qualifications
Master’s degree in Quality Management, Engineering, or a related field, or Bachelor’s degree with significant experience in a quality‑related role.
Minimum 12 years of experience in the medical device industry, with at least 8 years in a leadership position within a Quality Systems department.
Demonstrated expertise in FDA regulations, including QSRs, and relevant international standards, such as ISO 13485.
Expert understanding of Quality Management System principles and implementation methodologies.
Proven ability to build and lead high‑performing teams, fostering a collaborative and proactive work environment.
Excellent communication, interpersonal, and presentation skills.
Meticulous attention to detail and ability to manage multiple priorities effectively.
Strong analytical and problem‑solving skills with a data‑driven approach to quality improvement.
Hands‑on experience with both SaMD and hardware medical devices.
Working knowledge of project management tools and techniques is required.
Six Sigma, RAC, ASQ certification is preferred.
Lead auditor qualifications.
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.
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.
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.
Basic Life Insurance and Accidental Death and Dismemberment. Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) available for purchase in accordance with those plans.
Flexible Spending Accounts – Employees may be eligible to participate in a health care account, 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 (eligible after 20 hours or more of employment).
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.
Sick time is accrued throughout the year at the rate of one hour for every thirty worked hours. Unused sick leave can be carried over each year, up to a maximum balance of 80 hours.
11 company‑designated paid holidays throughout the year.
Paid parental leave up to 6 weeks for employees with at least 12 consecutive months of service (4 weeks if less than 12 months) and must be completed within one year of the birth or placement of the child.
Paid bereavement leave for three days.
Non‑exempt employees receive full pay for up to 10 days of jury duty. Exempt employees receive full salary during any week served.
Insurance options such as legal, critical illness, voluntary accident, long‑term care, auto, home and pet insurance are available for purchase.
Applicant Privacy Policy Review our Applicant Privacy Policy for additional information.
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.
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