Sr. Quality Management Systems Engineer

4 days ago

San Jose, California, United States Align Technology Full time

Department:
Quality

Location:
US-California-San Jose

Compensation:
$133,100 - $183,000 / year

Description
This position is ideal for experienced quality professionals to join the Quality Management team as a Sr. Quality Management Systems (QMS) Engineer, leading quality system integration and compliance efforts. Partnering with cross-functional and global teams, you'll provide strategic direction and hands-on support for implementing and maintaining compliant Quality Management Systems. This role is vital in ensuring regulatory compliance and continuous improvement across Align Technology's operations.

Role expectations

  • Conduct gap assessments on remote site Quality Management Systems
  • Develop and maintain Quality plans for the integration of new entities into the Align QMS
  • Drive QMS integration activities
  • Assist in onboarding entities as subcontractors and internal suppliers under Align QMS and support development of Quality Agreements
  • Assist in implementation of quality initiatives and corporate policies at the site
  • Guide functional and cross-functional teams in defining core quality system processes
  • Assist in maintaining ISO 13485:2016, EU MDD/MDR, FDA 21 CFR Part 820 compliant QMS
  • Conduct Quality Systems audits and provide training/guidance to other auditors
  • Assist with preparation and hosting of external Quality System inspections
  • Perform other duties as assigned

What We're Looking For

  • Education: Bachelor's degree in engineering discipline or equivalent.
  • Experience: Minimum 6 years of experience in a medical device environment.
  • Communication: Exceptional verbal and written communication skills.
  • Experience with mergers and acquisitions.
  • Experience with Software as a Medical Device (SaMD) and Device History Record requirements.
  • Teamwork: Ability to work independently and collaboratively; occasional travel required

Complementary skills

  • ISO 13485 and MDSAP auditor experience.
  • Skills: Creative problem-solving skills; ability to mentor others in Quality Management Systems.

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.

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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