Tecan Systems, Inc.
Ever wonder how your skills and unique background could impact the world of tomorrow? Join our Quality Assurance team and bring your passion and talent to work.
Compliance Specialist II
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, Customer Quality surveys). Multi-task on a variety of Quality System improvement initiatives in a hands-on environment to ensure company products are in compliance with required regulatory agency requirements. (i.e., FDA, ISO 13485, etc.)
- 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 actions.
- 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.
- 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.
- Possess understanding of FDA Quality System Regulations and ISO 13485
- Ability to work well under pressure, to multi-task
- High level of commitment and initiative
- Ability to influence others and lead/coach other employees to complete required documentation for CAPA/NCR, etc.
- Must be responsive to internal stakeholders and customers
- Must be computer literate and familiar with Microsoft office products. Microsoft Visio skills desired.
- Occasional travel is required.
- Requires excellent written and verbal communication skills, including good facilitation skills, excellent presentation skills and engaging presentation style. Must have good technical writing skills
- Quality auditing and CAPA experience desired.
- Strong attention to detail required
- Ability to prioritize.
- Ability to manage time effectively.
- A desire to make the difference!
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 change to grow your career within the company
- Feel empowered by our strong and unique company culture
- Comprehensive Compensation and Benefits package, including medical, dental, vision, and 401K match
- Wide range of training courses
- 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.
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