Quality Engineer

Work Flexibility: Hybrid

Responsibilities and duties

• Knowledge of Change control Procedures and Processes.
• Develop, establish, and maintain documentation quality systems as per ISO 13485 within the organization to ensure that all necessary systems and procedures are in place to satisfy customer requirements and audits.
• Knowledge of QMS systems would be highly desired.
• Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness
• Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight
• Implement and manage key performance indicators (KPIs) for change management domain
• Ensure quality systems deliver cost effective results at all stages and across all relevant areas.
• Communicating frequently across all project stakeholders to ensure project team and senior management are aware of upcoming milestones and risks/issues.
• Support in the preparation, participate and follow up to Internal/external audits
• Demonstrated experience processing ECNs, CAs and procedural documentation through electronic document management systems.
• Good experience of working with multiple teams and collaborating across geographically spread multi-functional teams
• Understanding of medical device regulations applicable to devices, particularly standards

Experience/skills required

• Total experience of 1-5 years with effectively working in QMS.  Healthcare domain will be preferable
• Educational qualification - Bachelors in Mechanical Engineering/Bio-Medical Engineering
• Knowledge of Windchill/One PLM or a similar system will be an added advantage.
• Good analytical and problem-solving skills.
• Understanding of NC, CAPA & QMS terminologies
• Excellent communication skills.
• Influencing /leading without authority with Cross functional Team

Travel Percentage: None