Quality and Compliance Engineer - Fremont, CA

What you will accomplish together with us

• Provide Quality Management Systems expertise to assure compliance of the Quality Management System to ISO Certification Requirements
• Oversee the Customer Complaint Handling processes; ensure Containment Root Cause Investigation and Corrective Countermeasures are implemented.
• Working with Technical Support ensure resolution and communication of quality issues between plant and customer
• Represent Quality Function during ISO Registrar Audits
• Maintain strengthen and further develop the Quality Management System
• Support manufacturing engineer in process validations process control process training programs process improvement risk management and software validations and control
• Develop protocols for validation evaluate data and write reports
• Perform studies on new equipment to establish control points and proper settings
• Serve as resource for problem identification improvement and resolution
• Prepare reports to evaluate effectiveness of quality systems
• Provide support for customer representatives regarding quality issues
• Work with suppliers to resolve or improve quality issues and to implement effective corrective action
• Develop and maintain quality standards and requirements for design/development projects; serve on NPI core teams representing the QA/Compliance Functions
• Perform internal audits of quality management systems compliance to ISO 9001
• Audit and monitor complianceto RoHS REACH CE Marking and other regulatory compliance requirements
• Coordinate customer complaint handling processes including overseeing investigations of root cause and corrective and preventive measure implementation
• Coordinate internal non-conforming materials handling processes; ensure that root cause investigations and associated implementation of corrective and preventive measures are in place internally and at suppliers
• Calculate and coordinate Quality metrics and KPIs reporting including tracking and trending against improvement targets
• Coordinate Management Review process and meetings
• Work cooperatively in a team environment to reach common results and goals

What will convince us:

• Bachelors degree in Science Engineering or related field
• 3 years of experience with QA and Compliance responsibilities
• Detail oriented with strong organizational skills
• Good problem-solving abilities; knowledge and experience with formal Design of Experiments (DOE) a plus
• Knowledge of and experience with ISO requirements a must; GMP experience a plus
• Knowledge of and experience with instrument reagent and consumables products and associated compliance requirements including RoHS REACH CE Marking and WEEE.
• Excellent computer skills with an aptitude in Excel Word and statistical software
• Good team player
• Excellent written and interpersonal communication skills
• Team working capabilities
• Logical self-motivated energetic results oriented and can work under high pressure
• Proven software skills e.g. Microsoft Office SAP are required
• Identification with our core values: Sustainability Openness Enjoyment

Compensation for this position will be a base salary between $75k and $90k.

What We Offer

As a growing global life science company with our stock listed on the German DAX and TecDAX Sartorius offers a wide range of benefits:
Personal and Professional Development: Mentoring leadership programs internal seminar offerings
Worklife Balance: Paid vacation sick time corporate holidays and community service day; as well as flexible work schedules
Making an Impact Right from the Start: Comprehensive onboarding including a virtual online platform
Welcoming Culture: Mutual support team spirit and international collaboration; communities on numerous topics such as Coaching Agile Working and a Businesswomens Network
Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from dental vision EAP and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.

Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA FSA (dependent care & healthcare spending) Transportation Commuter Account
Company Paid Benefits: Basic Life Insurance AD&D EAP Family Planning & Womens Health Health Advocate
Additional/Optional: Supplemental Life Insurance (employee spouse & dependents) Legal Services LTD & STD Critical Illness Insurance Student Loan Tuition Refinance Service

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex national origin age protected veteran status disability or based on status in any other protected group of class.

Please view equal employment opportunity posters provided by OFCCP here.

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Sartorius is part of the solution in the fight against cancer dementia and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.

We look forward to receiving your application.

you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex national origin age protected veteran status or disability or based on status in any other protected group of class.

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at

About Sartorius

Sartorius is part of the solution in the fight against cancer dementia and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application.