Job description
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 Team.
Job title: Jr. Quality Engineer
Salary: $65,000 – $75,000 Annually
SUMMARY: The Quality Engineer is 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) and production processes are in compliance, participating in risk management, monitoring and analyzing results of in process QC tests, review of batch records, review related complaints, review nonconformances (NC) and Corrective and Preventive Actions (CAPA), create procedures and work instructions and facilitate their training to affected teams, and determination of acceptance decisions. Additionally, this position will participate in root cause investigations (e.g. complaints, nonconforming materials, NC’s, CAPA’s, etc.) and ensure compliances to designated regulatory standards (i.e. ISO 13485, 21CFR820, etc.).
Reports to: Director of Quality
What you do:
- Develop, maintain, and execute detailed project schedule to monitor and track progress of CAPAs, NCs, Complaints, and Projects as assigned.
- Participate in root cause investigation studies as assigned. Document results and conclusions
- Measure and report project status using appropriate tools, techniques and metrics.
- Report and escalate to management potential issues as needed
- Proactively anticipate and identify risk areas and alert stakeholders
- Maintain compliance with all Quality and Design Control Systems
- Support audit and regulatory compliance activities (FDA and ISO audits, design controls)
- 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
- Execute raw material sorbent screening tests for acceptance of new sorbent lots for consumable production in accordance with established methods as deemed necessary
- Monitoring in process and final QC inspection results and conducting studies to evaluate QC methods for improvements. Executing selected QC testing as deemed necessary
- Prepare and maintain Technical Files
- Review of Design History Files for completion
- Review and approve and maintain Device Master Record (DMR), and Device History Records (DHR)
- Determining product acceptance in accordance with established acceptance criteria per established procedures
- Review, approve, and/or initiate Validation Protocols and Reports, Work Instructions, Procedures, etc. for compliance to Quality and Tecan requirements
- Ensuring nonconforming materials are quarantined in accordance with established procedures
- Perform internal audits in accordance with established audit program.
DUTIES AND RESPONSIBILITIES 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 THAT MAY BE ASSIGNED DURING NORMAL OPERATIONS.
What you Bring:
- Minimum education requirement Bachelor Degree.
- Demonstrated organizational skills and ability to multi-task and balance demanding workload for both instrument and consumable/reagent product lines.
- 1 to 2 years of experience in a QA role in a GMP manufacturing environment.
- The equivalent combination of education and experience will be considered.
- Experience in ISO 13485 and 21CFR820 regulated environment
- Experience with analytical chemistry preferred.
- Have a positive attitude and be a team player, self-motivated, energetic, and quality driven mind-set.
- Ability to be organized, be able to follow directions, and be open to learn and accept changes in hands-on attitude.
- Ability to solve practical problems using critical thinking.
- Ability to interpret a variety of instructions furnished in written, oral, or schedule form
- Must be reliable, punctual and have good attendance.
WHAT MAKES WORKING AT TECAN UNIQUE:
- The chance to make it count and to have an impact on the world of tomorrow
- Working in an international and diverse environment
- The chance to grow your career within the company
- Feel empowered by our strong and unique company culture
- Comprehensive compensation and benefits package
Join Tecan, a great place to work! Read about our recent certification from Great Place to Work.
We’re looking forward to receiving your application online. Please submit your CV or resume (w/o picture and w/o cover letter, reference letters and diplomas are optional).
Only applications that fully meet our requirements will be considered.
Our purpose.
At Tecan we are driven to improve people’s lives and health. We do this by empowering our customers to scale healthcare innovation globally from life science to the clinic. We collaborate with our customers from early-stage innovation through project implementation and beyond. We deliver the products, services and solutions that make lab processes and medical procedures precise, reproducible and compliant.
Stay unique and make it count.
Our values - trust, highest standards and ambition - are the cornerstones of our business and provide the framework for Tecan's culture. We foster a positive and empowering environment where our rarest assets, our unique employees, can grow and bring their passion and talent to work.
Tecan SP, Baldwin Park CA, 91706, www.tecan.com, United States
Our purpose.
At Tecan we are driven to improve people’s lives and health. We do this by empowering our customers to scale healthcare innovation globally from life science to the clinic. We collaborate with our customers from early-stage innovation through project implementation and beyond. We deliver the products, services and solutions that make lab processes and medical procedures precise, reproducible and compliant.
Stay unique and make it count.
Our values - trust, highest standards and ambition - are the cornerstones of our business and provide the framework for Tecan's culture. We foster a positive and empowering environment where our rarest assets, our unique employees, can grow and bring their passion and talent to work.
Nearest Major Market: Los Angeles
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