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AlignTech Sr Quality Management Systems Engineer United States, California, San Jose 225794925
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- Employment Type
- Full Time
- US-California-San Jose
- Workplace type
- $133,100 - $183,000 / year
- 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
- 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
- ISO 13485 and MDSAP auditor experience.
- Skills: Creative problem-solving skills; ability to mentor others in Quality Management Systems.
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.
Your growth and well-being:
- Health and well-being programs to keep you thriving in both body and mind.
- Employee-exclusive discounts on Invisalign products.
- Learning opportunities through online learning resources and support for your individual development plans.
- Inclusive, global workplace that fosters collaboration, recognition and belonging.
Country and/or role specific details will be shared with you by your recruiter during the interview process.
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