Quality Engineer

Varian

About the job
Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world’s best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

If you want to be part of this important mission, we want to hear from you.

Interface directly with suppliers as well as cross functional partners to help obtain materials and services for our life saving devices. Communicate product specifications to suppliers and assess the supplier’s ability to meet Engineering, Regulatory and Quality requirements. Work extensively with suppliers and cross functional partners to resolve supplier quality issues.

This Position Is Responsible For

Evaluating suppliers’ Quality Management System and internal processes to assess their overall ability to provide materials that meet specified requirements.
Qualifying suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
Monitoring parts from acquisition through the manufacturing cycle and communicating and resolving supplier-related problems as they occur.
Developing and prioritizing an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure Good Manufacturing Practices (GMP) and quality standards are met.
Performing assignments independently by applying Good Manufacturing Practices (GMP) in all areas of responsibility to ensure our customers receive the highest possible quality products.
Managing the supplier quality activities for assigned suppliers.
Ensuring that suppliers deliver quality parts, materials, and/or services.
Monitoring supplier provided parts quality performance through Varian incoming inspection and manufacturing processes and takes appropriate action.
Communicating and resolving supplier-related issues through the Non-Conforming Material process and when required the Supplier Corrective Action process.
Lead Auditor for supplier audits to ensure supplier meets International Quality Management Systems standards and Varian Requirements

Minimum Required Skills And Knowledge

Proven experience working with and understanding Quality System requirements in the medical device industry, such as 21CFR820, ISO 13485:2016.
Experience conducting audits.
Understanding of manufacturing processes (e.g. welding, injection molding, machining) preferred and Lean Six Sigma methodology.

Other Desired Skills And Knowledge

Routinely suggests process improvements
Problem-solving skills
Accuracy and a methodical approach to work
Serve as a mentor to others
The ability to work well in a team and
Ability to prioritizes tasks to meet commitments
Excellent communication skills, both oral and written.
Ability to communicate appropriately across functions and at all levels.
Ability to work with geographically diverse and international teams.

Experience Level With Business Tools

Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, Visio, and PowerPoint.
Experience with SAP or equivalent ERP and productivity software desired.

Knowledge

Knowledge in FDA, QSR, MDD, EU MDR and ISO requirements
Knowledge of manufacturing processes (e.g. machining, welding, sterilization) preferred
Knowledgeable in advanced statistics, process control, design of experiments, etc.
The ability to read and interpret engineering drawings.
Working knowledge of Microsoft Office applications or other applicable software applications.

Job Complexity

Work location Pune – working from office in hybrid working mode (3-4 days a week work from office) is essential.
Work in Europe working hours (IST 2 PM to 11 PM)for work hours overlap and cross country collaboration with US and European site, would require to work during USA-CST working hours.
Supports an environment of changing priorities.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Exercises independent judgment and discretion in solving complex business problems. Interacts with all levels of the organization.

Interaction

Ability to interact at the highest professional manner with organizational levels.
Excellent communication skills, both verbal and written, and interpersonal skills to effectively interact with and contribute constructively to a global team environment, outside, departments and externally.
Builds productive internal/external working relationships.

Required Education And Experience

Bachelor’s or Masters Degree in Engineering or equivalent with 5 years of related experience.
One or more quality certifications required (e.g. ASQ – CQE, CQA, CBA). Lean Six Sigma Green Belt or higher is also preferred.

Upload your CV/resume or any other relevant file. Max. file size: 512 MB.

Check Also

Hill International Jobs & Careers in Middle East

Hill International is a global construction management and consulting firm, specializing in overseeing complex infrastructure …