Quality Operations Engineer

Job Description

Job Description Job ID: CEP004746
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 Operations Engineer
  Job Location: India-Karnataka-Bengaluru
  GCRF Job Level: P1
  GCRF Job Family: Quality and Regulatory Affairs
  POSITION SUMMARY:
  • The Quality Operations Engineer will support Quality Systems activities related to new product development, manufacturing sustainment and risk management activities, in accordance with European, India, FDA and ISO regulations.
  • 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 manufacturing operations quality at Cepheid India Private Ltd.
  ESSENTIAL JOB RESPONSIBILITIES:
  New Product Introduction (NPI) and Change Control Activities:
  • Ensure that DMRs are complete and accurate as part of NPl/design transfer to manufacturing.
  • Review Changes Requests and deviations according to change order guidelines, ensuring impact for Major change(s) is outlined and evidence of required activities, and reason for change is clear and accurate.
  • Ensure maintenance of validated state, and consideration for re-validation during various design and process changes.
  • Ensure maintenance of product ID and traceability, including that of safety critical parts.
  • Review and approve the criteria for WIP reworks and re-inspections.
  • Drive improvements in process capability and quality of products.
  Supplier Quality Support:
  • Facilitate and support suppliers in efforts to establish robust manufacturing processes during and after NPI.
  • Conduct site visits during NPI and sustaining to provide training and ensure quality requirements are met.
  • Ensure change control, maintenance of validated state, and product ID and traceability during various design and process changes.
  • Support manufacturing engineering and IQC in conducting FAIS from suppliers.
  • Communicate requirements for quality to supplier and provide/obtain feedback for outstanding issues.
  • Ensure continuity between Sustaining, CAPA and QRB teams.
  Failure Investigations and Corrective Actions:
  • Regularly monitor, investigate and review nonconformance activities and generate CAPAs/SCARs based on trends/issues identified from operations, MRB and drive them to closure.
  • Investigate failures for field/customer, in-coming and in-process problems and execute corrective actions.
  • Proactively identify potential problems and drive continuous improvement, utilizing the CAPA/SCAR and other processes.
  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:
  • Master’s degree in science (Biochemistry, Biotechnology, Pharmacy)/BE biotech/biomedical engineering/ BE mechanical engineering, medical or technical field and 2+ years’ experience with increasing responsibility in engineering area.
  • Experience with in Medical device and Vitro Diagnostics (IVD) is very beneficial and highly desirable
  • Quality Assurance Engineering background in molecular diagnostic products utilizing nucleic acid amplification.
  • Quality competent technical person approved as per D&C act if any.
  Minimum Experience Required:
  • 2-5- years’ experience in quality assurance field in a medical device manufacturing environment
  • In-depth knowledge of SPC, and process capability studies.
  • Working knowledge of the MDR, IVDD medical device Quality Systems Regulations and ISO 13485.
  • Experience with failure investigations, risk management and failure report writing,
  • Excellent written and oral communication skills
  • Ability to create concise, accurate report
  • Ability to read technical reports and specifications
  • Proficiency in the use of personal computers and computer database software, including Microsoft Office applications (Access, Excel, Word and PowerPoint).
  • Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
  • Must show self-initiative but be comfortable in the role of a team player. Must be able to manage multiple projects and report progress against goals in an objective manner
  • Project management experience
  • Excellent written, verbal and organizational skills required
  • Must be detail oriented and able to work independently
  • Minimum travel is required.
  Knowledge and skills:
  - Hands on Experience on IVD product testing.
  - Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS.
  - Must be flexible to work off-shifts and weekends as per production Schedule.
  - Schedule orientated (able to consistently maintains schedules and meet timelines)
  - Strong interpersonal skills, Effective organization and Communication.
  - Good skills in English language
  PREFERRED REQUIREMENTS:
  • Experience working with medical device quality systems in compliance with MDR and ISO 13485
  • Able to interpret quality problem and establish practical solutions within a dynamic business environment.
  • Experience in leading continuous improvement efforts, in both quality systems and products.
  • Knowledge of the process of establishing facility QMS certifications.
  • Cross functional experience with products and manufacturing processes to influence change at all levels within the organization
  • Certified Quality Engineer or Reliability Engineer
  • Experience in biomedical research instrument or medical device manufacturing
  • Hands-on experience in statistical analysis

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.