Philips Quality Engineer - Products & Systems in Pune, India

Roles & Responsibility:-

  • Establish and maintains the Quality Management System policies, processes and procedures to ensure compliance with the applicable domestic and international regulations as well as Philips Healthcare corporate policies.

  • Manage the internal audit program within the DMC India as well as coordinate audit schedules with the Corporate Compliance group

  • Prepares Management Review meeting

  • Lead HIC India sites in the preparation for and during external and internal audits as well as providing support for the development of responses to those audits.

  • Plans and executes the Business-Audit Year Program in cooperation with various departments.

  • Provide quality compliance consultation and mentoring to HIC India personnel

  • Assist and/or lead in HIC India compliance remediation projects and process development/improvement initiatives whenever needed.

  • Lead the delivery of quality training programs

  • Manage QMS trainings for the site and ensure the compliance

Job Knowledge, Skills & Experience:-

  • Engineering degree in Mechanical or Electronics/Bio medical /Life sciences

  • 10 – 15 Years of experience (medical device industry experience preferred) in QMS /AUDITS

  • 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 stake holder 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 trainings

  • 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.

In this role, the DQA Manager (Design Quality Assurance) provides guidance of Design Controls and the PRP process to the engineering core teams

You are responsible for support activities required to ensure reliability of the design. Work with key stakeholders to design, implement and maintain business solutions to address management of reliability requirements, clinical relevant test methods and Design Verification test plans, execution and reports

  • 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

  • Facilitate the identification and deployment of resources to investigate and resolve issues in a timely and effective manner.

  • 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.

  • 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

  • Support Post Market Product Assurance and audit groups in post-market activities.

  • Work with business process owners to identify and implement solutions to track 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

To succeed in this role, you should have the following skills and experience:

  • Engineering degree in Mechanical or Electronics/Bio medical /Life sciences

  • 10 – 15 Years of experience (medical device industry experience preferred) in QMS /AUDITS

  • 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 stake holder 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 trainings

  • 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.

Why should you join Philips ?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .