Quality Engineer

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

Join Team Tecan. Join the Market Leader! Work in an International and dynamic environment, and share our success!!

We care about people - Join the Market Leader

People Every day all around the work will benefit from more personalized healthcare. The promise of better, faster, more cost efficient solutions is now within our grasp. And that's the world in which Tecan plays a vital role- helping advance healthcare - through advance life science research and diagnostic solutions. We constantly seek new ways to steer innovation.

Every lab. Every day. Empowered.

Our Vision is to empower every laboratory, every day, around the worked with Tecan technology, products and support. We will help to shape the future of automated workflow in life sciences and clinical diagnostics through unrivaled expertise, product 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 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”.

And we need you to join our Team in Baldwin Park, California

What you will do as our Quality Engineer:  

Summary:  

 Responsible for conducting selected activities for review and inspection of components and/or finished products, including but not limited to consumables and instrument product lines. This position must be flexible and able to multi-task. Responsibilities include ensuring design control (design and development records for accuracy and release) is in compliance, participating in risk management, monitoring and analyzing results of in process QC tests, review of batch records, review related complaints, review NC’s and CAPA’s, create SOP’s and facilitate training, and determination of acceptance decisions. Additionally, this position will participate in root cause investigations (e.g. complaints, nonconforming materials, NC’s, CAPA’s, etc).

REPORTS TO: Director of Quality/Regulatory

DUTIES AND RESPONSIBILITIES  

1. Develop and maintain a detailed project schedule to monitor and track progress of CAPA’s and Projects as assigned.
2. Participate in root cause investigation studies as assigned. Document results and conclusions
3. Measure and report CAPA/project status using appropriate tools, techniques and metrics.
4. Report and escalate to management potential issues as needed.
5. Proactively anticipate and identify risk areas and alert stakeholders.
6. Maintain compliance with all Quality and Design Control Systems.
7. Support audit and regulatory compliance activities (FDA and ISO audits, design controls).
8. Participate in Risk Management activities such as; reviewing and approving risk documents when appropriate; participating in risk management review meetings; Providing or ensuring that information necessary for risk management activities is provided/obtained; reviewing and mitigating new risks based on the data reviewed.
9. Execute raw material sorbent screening tests for acceptance of new lots for consumable production in accordance with established methods as deemed necessary.
10. Monitoring in process and final QC inspection results and conducting studies to evaluate QC methods for improvements. Executing selected QC testing as deemed necessary.
11. Prepare and maintain Technical Files
12. Review of Design History Files for completion.
13. Review and approve and maintain Device Master Record (DMR), and Device History Records (DHR).
14. Determining product acceptance in accordance with established acceptance criteria per established procedures.
15. Review and approve Validation Protocols
16. Ensuring nonconforming materials are quarantined in accordance with established procedures.
17. Participate in root cause investigation studies as assigned. Document results and conclusions.
18. Assist Engineering, Operations & R&D personnel to conduct experiments, design transfer studies, or product surveillance and monitoring studies.
19. Practicing safe operations by adhering to safety procedures and regulations
20. Perform assigned quality trending activities for products.
21. Support the Quality System and Quality Policy by following procedures / work instructions and creating records to meet the requirements of Tecan SP’s’s Quality System.

DUTIES AND RESPONSIBILITEIS INCLUDE THE PRINCIPAL FUNCTIONS OF THE JOB. THE JOB DESCRIPTION SHALL NOT BE CONSTRUED AS A COMPLETE LISTING OF ALL MISCELLANEOUS, INCIDENTAL OR OTHER DUTIES, WHICH MAY BE ASSIGNED DURING NORMAL OPERATIONS.

TRAINING, EXPERIENCE AND SKILL REQUIREMENTS:

TRAINING EXPERIENCE AND SKILL REQUIREMENTS:

• Bachelor of Science Degree in Chemistry or similar discipline
• Demonstrated organizational skills and ability to multi-task and balance demanding workload in a GMP environment.
• Experience with basic laboratory instrumentation.
• Define and analyze various sources of quality data to ensure continuous improvement of product and processes.
• Inspect completed work for accuracy, conformance and high standards
• Must have a positive attitude and be a team player, self-motivated, and energetic
• Must be organized, be able to follow directions, and be open to learn and accept changes in a fast paced environment.
• Experience in the medical device manufacturing industry (FDA regulated, ISO 13485)
• Knowledge concerning medical device manufacturing including materials, processes, and regulations
• Proficiency on computers including prior experience with ERP systems, project management, Microsoft Office
• Strong analytical skills – able to provide analysis of data for purposes of defining capability of processes and supplier performance, and statistical analysis
• Proven dependability and adherence to company attendance standards.
• Minimum of 1-3 years of experience in Quality Assurance/Quality Control using a variety of laboratory instrumentation. Experience with LCMS is preferable. Able to learn use of new automation and software programs quickly.
• Knowledge of statistical techniques including using basic ANSI sampling plans preferred.
• Proficient with Microsoft Office suite

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee frequently may be required to sit and stoop, kneel, crouch, or crawl. The employee must be able to lift and/or move up to fifty (50) pounds.

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

Look no further and apply now!

Tecan is an equal opportunity employer. All qualified applicants will receive considerations for the employment without regards to race, religion, color, national origin, sex, age, status as a protective veteran, or status as a qualified individual

We care about people - Join the market leader People every day all around the world will benefit from more personalized healthcare. The promise of better, faster, more cost efficient solutions is now within our grasp. And that’s the world in which Tecan plays a vital role – helping advance healthcare – through advanced life science research and diagnostic solutions. We constantly seek new ways to steer innovation.

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’.

Always there for you