Quality Calibration Technician

Job Description

Job Description Job ID: CEP004747
About Us
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at [ Link Removed ] or follow us on Twitter (@CepheidNews).
Description

• Job Title: Quality Calibration Technician
  Job Location: India-Karnataka-Bengaluru
  GCRF Job Level: P1
  GCRF Job Family: Quality and Regulatory Affairs
  POSITION SUMMARY:
  • Calibration Technician will perform calibration tasks ensuring work is compliant to Cepheid Quality Policy and regulatory agency requirements.
  • Reporting directly to the head of India Quality System and Regulatory Compliance (QSRC) manager, this position will be responsible for managing the day today activities of calibration and repair of test and measurement equipment in site at Cepheid India Private Ltd.
  ESSENTIAL JOB RESPONSIBILITIES:
  • Perform multi-discipline internal calibrations and simple measurement systems, coordinate external calibrations, and maintain the calibration schedule with all calibration documents
  • Perform calibration service in accordance with established SOPs and regulations
  • Troubleshoot and conduct failure analysis of automated and laboratory equipment by performing operational test and fault isolation
  • Handle basic, non-complex, and complex products and/or problems, escalating issues to Lead and\or Manager.
  • Work with multiple departments, including the manufacturing floor and various types of Labs
  • Contacts external vendors to arrange for service.
  Process Validation and Manufacturing Process Support
  • Provide support to process validation and other processes on the manufacturing floor, warehouse and facilities as required.
  Quality System Support:
  • Support global initiatives/QSl Ps and ensure that required activities are carried out, including pertinent personnel planning, training and resourcing.
  All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
  TRAINING RESPONSIBILITIES:
  • Complete all assigned and required training satisfactorily and on time

Job Requirements
Qualifications

• MINIMUM REQUIREMENTS:
  Minimum Education Required:
  • BE Mechanical engineering, medical or technical field and 2+ years’ experience with increasing responsibility in engineering area.
  • Experience with in Medical device is very beneficial and highly desirable.
  Required Knowledge, Skills, And Abilities
  • AA or Technical Trade Degree with 2-4 years of work experience
  • Formal training in Metrology, such as the PMEL, TMDE, or ASQ CCT highly desirable
  • Minimum of 2 years hands on experience working as a calibration technician and medical device manufacturing environment
  • Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization
  • Excellent verbal and written communication skills with ability for effectively communicate at multiple levels in the organization
  • Knowledge of Quality Systems, ISO 13485, ISO 17025 and applicable worldwide regulatory requirements preferred
  • Solid understanding of AC and DC electrical wiring (i.e., current/voltage ratings, circuit breakers, and safety precautions)
  • Proficient with Microsoft Office, and Internet applications with an emphasis on Excel & Word required
  • BMRAM Database knowledge preferred
  • Hands on experience troubleshooting, repairing, and maintaining laboratory and facilities equipment required.
  • Knowledge of AC/DC, temperature and pressure calibration required
  • Very organized, reliable, dependable and customer service oriented
  • Flexibility to work overtime and weekends, as required
  Physical Requirements/Abilities
  • Flexibility to work overtime and weekends, as required
  • Must be able to lift 50 lbs.
  • Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.
  PREFERRED REQUIREMENTS:
  • Formal training in Metrology, such as the PMEL, TMDE or ASQ CCT
  • Familiar with domestic and international quality systems and other standards such as MDR, MDD, ISO 13485, and other applicable standards and regulations

Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.