Director, Quality Systems
Align Technology, Inc., Raleigh, North Carolina, United States, 27601
Director, Quality Systems
Department:
Quality
Employment Type:
Full Time
Location:
US-North Carolina-Raleigh
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.
Role expectations
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 towards 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 premarket 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%
What we're looking for
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
A 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.
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.
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Quality
Employment Type:
Full Time
Location:
US-North Carolina-Raleigh
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.
Role expectations
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 towards 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 premarket 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%
What we're looking for
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
A 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.
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.
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