Senior Quality Engineer

Who we want:

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in function
• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate
• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  

What You Will Do

• Independently processing results of PFA assessments.
• Initiate, organize and coordinate global containment actions
• Ensure that data is documented for the different sites.
• Together with the PFA specialist create a communication to affected parties.
• Provide necessary information to regulatory compliance team for reporting.
• Presenting PFA/commercial hold relevant processes and cases during audits
• Preparing weekly, monthly and quarterly Commercial Hold relevant statistics
• Performing training of colleagues and managers by procedural changes
  

What You Need

• B. Tech / M.Tech Mechanical, Biotechnology with hands on experience of working on PFAs, and Commercial Holds.
• Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability.
• Poses the ability to lead colleagues in other departments to perform the necessary actions for a timely Containment action
• Hands on experience of Risk Management process as per ISO 14971 Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.
• Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment.
• Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
• Sound knowledge on complaint handling process of medical devices will be an added advantage
• Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).
• Good understanding of FDA 21CFR Part 822 / 820 (Good to have)