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Join Tecan! Join the market leader!
Work in an international and dynamic environment, share our success!

Do you want to make a significant difference in how the world is looking tomorrow and contribute to the innovation of state-of-the-art, cutting-edge technology products?

Then look no further and join our Quality team in San Jose, CA as

Supplier Quality Engineer

Reference # 093-020

What you will do 

With primary focus on Supplier Quality, responsible for driving overall quality performance, improvement and compliance throughout the organization.  Partners with Management, Regulatory, R&D, Marketing, Product Support, Design Transfer, Operations, Suppliers and others to ensure effective product development, process improvements and investigations and CAPA.  Ensure that supplier systems are aligned with current regulatory requirements, standards, industry trends and Tecan policies and standards.

 

Responsibilities will include 

  • Aid in the definition of supplier quality specifications, sampling plans and vendor qualification.
  • Perform root cause analysis and implement corrective actions for product and process related activities, e.g. CAPA, complaints, and SCARs.
  • Responsible for planning, organizing and managing the overall activities of receiving inspection and final QC quality functions including, but not limited to managing and training operators and inspectors and providing technical guidance to RI inspection team. 
  • Work directly with suppliers to improve overall part quality and drive improvements to their quality systems.  Lead/Participate in negotiations of supplier quality responsibility agreements.
  • Conduct supplier audits.  Develop and implement efficient and effective inspection points and control plans at the supplier.  Conduct on-site technical and process assessments at suppliers to approve new suppliers and to monitor existing suppliers on an ongoing basis.
  • Monitor, trend, identify issues, and lead the resolution of supplier quality issues.
  • Generate appropriate performance metrics and prioritize and drive resolution of issues.
  • Provide input to Risk Management activities including FMEA and corrective actions.
  • Review and disposition non-conforming product, assess product regulatory requirements for concessions and support all MRB team-related activities.
  • May function as the process owner for any of the following processes: Corrective and Preventative Action (CAPA), Control of Nonconforming Product, Complaints Handling, Control of Quality Records, Supplier Management.
  • Develop and drive department projects such as: reducing the need for incoming inspections, vendor to stock improvement, electronic certificates of compliance, etc.
  • Coach and mentor other team members and Quality Engineers.
  • Support the Quality System and Policy by following the policies, procedures and work instructions and performing the responsibilities under the authority for this position. Complete the necessary actions to create records to meet the requirements for the Quality System Regulation, applicable ISO standards and the legal regulations applicable to Tecan Systems, Inc.

 

What you bring along 

  • BS in ME/EE preferred, plus 5 years of Quality Engineer experience in support of product development and manufacturing.
  • Understands and applies principles, concepts, practices and industry standards, specifically FDA QSR/ISO 13485.
  • Requires excellent written and verbal communication skills, including good facilitation skills and good presentation skills.
  • Must be proficient in Microsoft Office products.  SAP and Minitab experience a plus. Competency with other database/programs desirable.
  • Capable of reading and interpreting engineering drawings and specifications.
  • Strong Geometric Dimensioning and Tolerance (GD&T) skills a plus. Demonstrated strong analytical problem solving (CAPA) skills.
  • Project management and leadership skills, including the demonstrated ability to lead the Quality function in multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Must be able to communicate effectively at varying levels and with an international audience.
  • ASQ,CQE, and Six Sigma a plus.

 

What you will get 

  • Comprehensive Compensation and Benefits package
  • Progressive employment conditions
  • Exciting career opportunities
  • Wide range of training courses
  • International and diverse environment (30+ different nationalities)
  • Strong company culture with rich history

 

Look no further and apply now!

We are looking forward to receiving your application online. Please submit your resume (w/o picture and w/o cover letter, reference letters and diplomas are optional).

 

We will only consider applications that fully meet our requirements.

 

Tecan is an equal opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, status as a protected veteran, or status as a qualified individual with disability.

 

#lifescience #healthcare #automation #medical device #quality 

 

 

Every lab. Every day. Empowered.
Our vision is to empower every laboratory, every day, around the world with Tecan technology, products and support. We will help to shape the future of automated workflows in life sciences and clinical diagnostics through unrivaled expertise, products and customer support.

We care about our culture.
Our values – trust, highest standards and ambition – are the cornerstones of our business, and give us the framework for the Tecan culture. We foster a positive and empowering environment, which allows us to bring our passion and energy to work. This helps us to deliver on our customer promise – ‘Always there for you’.

Legal entity:  Tecan Systems, Inc.
City:  San Jose,CA
Country:  US


Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto