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

 

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 Morrisville, NC as

Compliance Specialist II

What you will do

The Compliance Specialist II is responsible for the daily operation of the quality assurance processes included but not limited to CAPA, Auditing, Nonconformance Reports, Calibration, Customer Facing activities such as Complaint Management, Quality Holds, Field actions, and Customer Quality surveys.

 

Responsibilities will include

  • Responsible for an effective Corrective Action/Preventive Action (CAPA) System through interaction with responsible individuals and/or departments.  Assist in the development and evaluation of the effectiveness of corrective/preventive action.                       
  • Responsible for an effective Incident Report process through interaction with responsible individuals and/or departments.  Assist in the development and evaluation of the effectiveness of corrective actions.

                                   

  • Conduct audits as needed.                            

                       

  • Develop external customer communication and manage field corrections.

 

  • Gather information and perform trend analysis of quality information to support Management Review.                                                                                                                        
  • Support development projects to ensure regulatory compliance with FDA, ISO 13485, QSR, internal processes, and satisfaction of the applicable customer requirements.                    
  • Conduct quality and safety trainings.                                                                                    
  • Support the Quality System and Quality Policy by following procedures/work instructions and creating records to meet the requirements of the Quality System Regulation.          
  • Assist in the preparation for inspections by regulatory agencies, external auditors, customers,
  •  etc.                                                                                                    
  • Perform other duties as required to the success of the Quality group and Tecan US.                    
  • Handles essential tasks as assigned, and responds to change productively.
  • Follows all local safety procedures, State and Federal OSHA Regulations, and reports any safety concerns.
  • Management of the Tecan US Calibration program.  Included facilitation of onsite and offsite calibration activities to ensure calibrated tools meet the requirements for their use.
  • Execution of the Tecan US field corrections and removals within the market unit.  Facilitation of all customer notifications and monitoring progress.  Includes direct interaction with customers and interaction multidisciplinary teams locally and globally within Tecan.

 

What you bring along

Skills

  • Team player
  • Conceptual thinker – strategic and as well pragmatic
  • Communication and interpersonal skills
  • Skilled at problem solving and critical thinking
  • Can analyze and prioritize tasks based on business need, workload, and team goals
  • Highly driven and self-motivated
  • Ability to assert oneself
  • Comfortable being involved in decisions involving organizational process in SAP 
  • Willing to take responsibility
  • Able to perform under pressure
  • Potential for giving Training
  • A desire to make the difference!

 

Experience

  • Bachelor's degree in scientific field or engineering is preferred for this position
  • Competence in the selection and use of root cause analysis tools and Techniques
  • 3-5 years of quality related professional experience in life science, medical device, or pharmaceutical industry required.
  • Working knowledge of QSR and ISO 13485 required.

 

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
  • Global mindset with “Swissness” at heart

 

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.

 

 

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’.

 

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 US Inc.
City:  Morrisville, NC
Country:  US


Nearest Major Market: Raleigh