Philips India Hiring | Quality Engineer Products and Systems | Engineering degree in Mechanical or Electronics/ Biomedical/ Life sciences |

Position – Quality Engineer Products and Systems
Philips India Limited
Exp. – 10 to 12 years
Location – Pune

Job description

• Establish and oversee systems for the escalation, monitoring, and communication of key quality issues
• Establish processes to ensure findings, risks, recommendations, and outcomes are clearly documented and communicated
• Contribute quality and compliance expertise and guidance to teams responsible for addressing specific quality issues.
• Provide oversight and monitoring of all phases of design to ensure compliance and timely resolution. Support and lead FMEA/Risk Management processes and activities.
• Hands-on experience in Reliability engineering and Life cycle test
• Work with business process owners to devise appropriate metrics to improve product and process
• Establish Quality Assurance process metrics. Trend, analyze, and report on quality data; develop recommendations based on data analysis
• Facilitating and owning CAPAs and driving it to closure
• Support Post Market Product Assurance and audit groups in post-market activities.
• Work with business process owners to identify and implement solutions to track the cost of poor quality. Evaluate for completeness, effectiveness and proper identification of root cause
• Monitor the effectiveness of implemented actions and overall effectiveness of the system
• Establish and support best practices for problem-solving, root cause analysis, and solution selection tools
• Provide subject matter expertise during internal and external quality system audits.
• Provide management with plans and status updates on assigned responsibilities and goals and escalate issues in a timely fashion

Qualifications

• Engineering degree in Mechanical or Electronics/Biomedical /Life sciences with over 10 years of experience.
• Sound knowledge of implementing and sustaining Quality Management system compliance as per ISO Regulations (ISO13485/ USFDA QSR)
• Demonstrated external audit management capabilities like handling Notified body audits/FDA audits/ Internal audits with stakeholder management &Follow up for E2E corrective actions completion
• Superior knowledge/application of all Quality System elements within Medical device Industry
• Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues./Expertise in Gap assessments wrt to new regulation s/standards and drive the compliance program
• Demonstrated record of successful project management, process development, and process improvement in QMS implementations and training
• Superior communication and mentoring skills, ability to build consensus at all levels including global interactions
• Demonstrated quality training delivery experience.
• NPI and design transfer experience will be an added advantage.
• A rewarding career in Philips with an attractive package. `
• An extensive set of tools to drive your careers, such as a personal development budget, free training, and coaching
• Opportunity to buy Philips shares and products with discount