Quality Engineer 9/2/2016
Tecan US Inc
San Jose, CA
JOB DESCRIPTIONAPPLY JOIN TECAN. JOIN THE MARKET LEADER.
Work in an international and dynamic environment.
Tecan Systems is a leading global supplier of solutions for the biopharma, forensic and diagnostic industries. The company is a leader in the development, production and distribution of liquid handling components used in advanced automation and detection solution for the world s leading life science laboratories.
Is it your ambition to contribute to the quality of life of humankind by enabling our customers to make the world and our community a healthier and safer place*
Reference Job #090-116
We are seeking the right individual to partner with local and global Engineering, customers, and suppliers to ensure effective product development. You will apply moderate to complex engineering principles to develop methods and procedures to continuously improve our products and processes, with latitude for independent action and decision.
1. Support Company goals in continued QSR and ISO compliance, training and
2. Participate on R&D project teams for development of new products or changes
to existing product. Responsible for incoming inspection criteria for new
components, creation and maintenance of supplier capability reviews
participation and input to design reviews and statistical analysis as input to V&V
3. Define supplier quality specifications, sampling plans and supplier qualification.
4. Perform root cause analysis and implementation of corrective actions for product
and process related activities, e.g. CAPA, complaints, SCARs.
5. Provide Quality participation and oversight in the investigation process.
6. Provide input to Risk Management Activities including FMEA and corrective
7. Provide guidance and participate in production process validations, e.g.
planning, approval process, V&V, creation of inspection plans, supplier process
controls, L&P process controls and implementation of statistical analysis.
8. Develop and drive continuous improvement projects for the quality department.
TRAINING EXPERIENCE AND SKILL REQUIREMENTS:
* BS in ME/EE preferred.
* Minimum 5 years of experience in a regulated industry e.g. medical device, automotive, etc.; preferably in
a product development and manufacturing environment.
* Understands and applies principles, concepts, practices and industry standards, specifically FDA QSR/ISO
* Excellent written and verbal communication skills, including good facilitation skills, and engaging
* Proficient in Microsoft Office. Excellent at MS Excel.
SAP or other ERP proficiency desirable.
* Capable of reading and interpreting engineering drawings and specifications.
* Must be able to communicate effectively at varying technical levels with an international audience.
* Demonstrated mechanical/electrical problem solving skills.
* Demonstrated strong analytical problem solving (CAPA) skills.
* Travel, domestic and international less than 10%.
* Able to stand or walk for prolong periods.
* Lift and carry up to 50 lbs.
* Perform repetitive motions with hands/fingers.
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.