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Company Name : Philips
Location : Bengaluru, Karnataka
Position : I&S – Quality Compliance Auditor
Job Description : Job Title
I&S – Quality Compliance Auditor
Job Description
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
You are responsible for
Assess risk for Business and it’s Product(s) and support prepare the annual audit plan, considering applicable regulations and statutory requirements for the Business and it’s Products to be covered as part of the audit
Plan, coordinate, schedule and execute internal QMS and/or product-focused audits per audit plan, to assess the compliance and effectiveness of the overall QMS of the Business.
Prepare and timely issue audit reports meeting Philips requirements
Review responses to audit findings for completeness and effectiveness
Participate in relevant organization-wide initiatives
Build and maintain audit management database with any in-house tool available
Prepare periodic reports related to audit management and provide to Management Representative (MR) for use as input to Management Reviews
Collate audit outcome data, analyze and feed information to Organization-wide improvement initiatives
Prepare, coach and mentor project/ program teams to participate in audits
Act as Lead auditor while auditing with co-auditors/ experts supporting during audits
Lead/ Support during Supplier audit
Assess risk for Business and it’s Product(s) and support prepare the annual audit plan, considering applicable regulations and statutory requirements for the Business and it’s Products to be covered as part of the audit
Plan, coordinate, schedule and execute internal QMS and/or product-focused audits per audit plan, to assess the compliance and effectiveness of the overall QMS of the Business.
Prepare and timely issue audit reports meeting Philips requirements
Review responses to audit findings for completeness and effectiveness
Participate in relevant organization-wide initiatives
Build and maintain audit management database with any in-house tool available
Prepare periodic reports related to audit management and provide to Management Representative (MR) for use as input to Management Reviews
Collate audit outcome data, analyze and feed information to Organization-wide improvement initiatives
Prepare, coach and mentor project/ program teams to participate in audits
Act as Lead auditor while auditing with co-auditors/ experts supporting during audits
Lead/ Support during Supplier audit
You are a part of
Describe in two to three lines the place of the role in the organization and the team culture.
To succeed in this role, you’ll need a customer-first attitude and the following
Pre-requisites:
Experienced professional with a full understanding of overall audit management including planning until closure, and has wide-ranging experience in auditing medial and non- medical products
Have or seek comprehensive knowledge of Business, products and services to which the auditor is assigned
Interact with cross functional teams during audit management
Lead audit management activities
Should have undergone training and be qualified as a Philips Lead Auditor
Constantly upgrade the knowledge and skills with changing and/ or new standards/ regulations, provide necessary inputs to the management
Preferred Skills:
Knowledge of applicable regulations and standards in the medical and non- medical domain, as applicable for the Business/ Product(s)
Knowledge of local statutory requirements applicable for the Business and Product(s), as applicable
Strong Auditing skills and audit training experience
Certified Lead auditor certification in ISO 9001:2015, ISO 13485:2016, EU MDR, 21 CFR 820, ISO 27001 (preferred) at minimum. Knowledge of any other standards and/ or regulations in addition, will be an advantage
Strong knowledge on risk management and CAPA
Desired skills:
Auditor certification from any accreditation body
Worked as auditor with any certification body or as consultant
Auditing Suppliers
Experience:
Graduate or post graduate qualification
At least 10-12 yrs of auditing experience in medical and non-medical field
Nature of role:
This is a full time role
Well conversant in English communication- both oral and written
Display auditor behaviour
Uphold confidentiality and integrity
This role may require international travel
In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There’s a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
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