Job TitleBack In The Game – Quality Engineer Products and Systems
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. 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 on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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