At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope just to name a few.
A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.
Job Function Summary :
Performs calibration of Inspections, Test and Measurement Equipment (ITME) and schedule calibration with vendors and ITME owners.
Job Functions : (Primary essential duties and responsibilities)
Working closely with Engineering, Quality Engineering, and outside equipment vendors, assist in defining calibration requirements. Interface with vendors to develop methods and equipment for complex situations.
Scheduling of outside sources when needed for calibration of equipment that is not performed in-house.
Work closely with Facilities and ITME owners to schedule and perform off-cycle calibration activities.
Work closely with Field Service Representatives to schedule and perform calibration activities.
Monitor calibration schedule to ensure necessary ITME equipment is properly calibrated in a timely manner.
Measure and calibrate ITME in production and other test equipment throughout the facility.
Record the results of ITME calibrations using the designated calibration software.
Investigation of equipment found out of its designated accuracy.
Required Skills and Abilities:
High school degree or equivalent required. An Associates degree and/or related certifications is preferred.
Experience and Education Requirements:
A minimum of three years of quality assurance experience with a working knowledge of calibration procedures and practices. Three years of related experience in an FDA regulated industry is preferred. Medical device or pharmaceutical experience is ideal.
Must have knowledge of metrology skills including a sound understanding dimensional tolerances and usage of precise mechanical measurement instruments.
Must be able to read mechanical blueprints and electrical schematics, accurately apply scientific formulas, and read and maintain laboratory notebooks.
Must demonstrate ability to be accurate and identify procedural inaccuracies and then make recommendations for improvements and effectively implement changes.
Must demonstrate ability to work independently, make effective decisions, and resolve technical issues.
Must demonstrate effective verbal and written communication and be able to effectively interact with all levels of the organization.
Must demonstrate the ability to work effectively in teams to achieve results.
Basic proficiency with Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.
Build Quality into all aspects of work.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to your job function).
You must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
Attend all required Quality & Compliance training at the specified interval.
Adopt the Beyond Compliance Quality Culture in the work environment; always meet and exceed requirements.
Must practice verbatim compliance (exact compliance, no interpretation) with corporate Quality and Regulatory procedures (As applicable to your job function).
If your job description requires customer facing activities, you must thoroughly understand and comply with the Customer complaint reporting process and complaint procedures (As applicable to your job function).
Must be able to promptly report any non-compliance issues to Chief QA, RA, Compliance officer or appropriate administrator, including the Compliance Hotline.
Must be competent with 21 CFR 820, 801, 803, 806 and any other applicable federal regulations, and Quality standards (As applicable to your job function).
Must not be debarred by FDA for work in any Medical Device or Pharmaceutical business.
Responsible for understanding and conforming with the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimized the effects on the environment.
Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.
Responsible for understanding and conforming with the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.
Internal and External Contacts/Relationships
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the worlds most desired medtech company.