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Philips Back In The Game – Quality Engineer Products and Systems in Pune, India


You are responsible for

  • Provides guidance of Design Controls and the PRP process to the engineering core teams as part of the core team

  • Ensures that all the design deliverable are met as per the process before releasing the product.

  • Is responsible for support activities required to ensure reliability & quality of the design

  • Works 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

  • Establishes and oversees systems for the escalation, monitoring and communication of key quality issues

  • Establishes processes to ensure findings, risks, recommendations and outcomes are clearly documented and communicated

  • Contributes quality and compliance expertise and guidance to teams responsible for addressing specific quality issues

  • Provides oversight and monitoring of all phases of design to ensure compliance and timely resolution

  • Supports and leads FMEA/Risk Management processes and activities

  • Works with business process owners to devise appropriate metrics to improve product and process

  • Establishes Quality Assurance process metrics, analyzes and reports on quality data, develops recommendations based on data analysis

  • Supports post-market product assurance and audit groups in post-market activities

  • Works with business process owners to identify and implement solutions to track the cost of poor quality

  • Evaluates for completeness, effectiveness and proper identification of root cause

  • Monitors the effectiveness of implemented actions and overall effectiveness of the system

  • Establishes and supports best practices for problem-solving, root cause analysis, and solution selection tools

  • Provides subject matter expertise during internal and external quality system audits

  • Provides management with plans and status updates on assigned responsibilities and goals and escalate issues in a timely fashion

You are a part of

Back in the Game

Back in the Game (BIG) is an internship initiative driven by the Diversity Council at Philips India. It is a 3 months paid internship program to facilitate experienced women talent transition back into the workplace after a break in their career.

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

  • Engineering degree in Mechanical or Electronics/Biomedical /Life sciences

  • 7 + 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 stakeholder management &Follow up for E2E corrective actions completion

  • Superior knowledge/application of all Quality System elements within the Medical Device Industry

  • Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues

  • Expertise in gap assessments with respect to new regulations/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

  • Experience in DFMEA, DfM

In return, we offer you

  • A pre-defined project.

  • A chance to apply functional expertise & leadership skills gained through past work experience with Flexible work timings

  • Access to leaders from Philips India in form of Project Leaders and Mentors

  • Attractive Project Stipend

  • The live project will be evaluated on completion and may/may not transition into a full-time employment at Philips based on performance & availability of suitable openings in the company.

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 . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video at .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at on our career website, where you can read stories from our employee blog at . Once there,you can also learn about our recruitment process at , or find answers to some of the frequently asked questions at .