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Quality Compliance Auditor

Company: Philips
Location: Cambridge
Posted on: January 15, 2022

Job Description:

Job TitleQuality Compliance AuditorJob DescriptionEffective Wednesday, December 8, 2021, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.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 betterLooking 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.In this role, you have the opportunity to:Assure international regulatory compliance of the Philips Hospital Patient Monitoring (HPM) quality system. Responsible to perform timely, detailed, and independent internal quality management system (QMS), product-focused, and/or clinical audits to assess regulatory compliance to applicable local and international regulations/standards and Philips requirements.You are responsible for

  • Performing internal audits as an Auditor and/or Lead Auditor per the established audit scope and objectives.
  • Planning, coordinating, and executing internal QMS and/or product-focused audits to assess the compliance and effectiveness of the overall QMS of the organizational unit(s) under audit.
  • Reviewing responses to audit findings for completeness and effectiveness.
  • Participating in Quality & Regulatory initiatives as a cross-functional contributor.
  • Supporting external audits as needed.You are part ofThe Quality Audit team within the central Quality function of the Hospital Patient Monitoring (HPM) Business at Philips. HPM is a software and solutions business encompassing patient monitoring and its capabilities.To succeed in this role, you'll need a customer-first attitude and the following
    • Bachelor's degree, or equivalent experience.
    • 3+ years experience in a regulated industry (medical device, IVD, biologics, or Pharma for medical audit programs).
    • Current certification with a recognized accreditation body (i.e. RAB-QSA/IRCA); OR successful completion of ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA); OR successful completion of a Lead Auditor Course.
    • Working knowledge of global governing regulations, requirements, and standards such as 21CFR Parts 803, 806, 820, 11; ISO 13485, ISO 9001, ISO 14971, European Medical Devices Regulations (2017/745), Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
    • Strong CAPA Knowledge and experience preferred.
    • Able to interact with varying levels of the organization.
    • Solid oral and written communication skills.
    • Working knowledge of CFR ISO and ICH guidelines governing clinical research, and applying principles of 21 CFR Part 11 to clinical systems preferred.In return, we offer youOur benefits can be found here: work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.Company relocation benefits will not be provided for this position. For this position, you will reside in or within commuting distance to location listedHow we work at PhilipsOur 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.Visit our careers website to explore what it's like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.Philips Electronics Ltd is committed to treating all people in a way that allows them to maintain their dignity and independence. We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.#LI-PH1

Keywords: Philips, Cambridge , Quality Compliance Auditor, Accounting, Auditing , Cambridge, Massachusetts

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