BenefitsPulled from the full job description
Full Job Description
Job Title
QMS EngineerJob 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.
- Supporting QMS manager to manage and harmonize all QMS management processes and ensure compliance to FDA, MDD/EU-MDR , ISO 13485 etc.
- Review and approve QMS documents and records, ensuring GDP compliance
- Support QMS manager to manage the transition /deployment of the PQMS and manage its deployment
- Collects and maintains documents & records of the latest revision level.
- Timely distribution of latest revision level documents & records to all appropriate users and ensures that obsolete documentation is removed from distribution / publication.
- Maintains the document management system an ensure fast retrieval of documents & records.
- Controls issuance of document numbers, including maintenance of proper document registers.
- Ensures proper document classification, sorting, filing and proper archiving.
- Reviews correct formatting and completeness of documentation and prepares document transmittals.
- Administer learning assignments by using the standardized training administration processe
- Create, manage and maintain standardized roles in the Learning ManagementSystem
- Establish Document Control support to authors and process owners/SME in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records
- Establish and manage proper document review processes
- Ensures availability/publishing of controlled documents
- Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business
- Manage document and record control
- Support internal and external Audits
You are a part of
The Philips Hospital Respiratory Care business group, supporting products including invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment. We believe that by understanding our customers’ problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.
Bachelor Degree in engineering or equivalent with interest in process management or process improvement.
- 3 to 5 years related experience in change control and/or document control field.
- Advanced MS Office skills, document control process understanding.
- Experience in change control and or document control field
- Procedural or Technical writing experience
- Good communication – effective written and oral communication skills, organizational and project management skills
- Be familiar with ISO 13485, ISO 9001, 21CRF 820
- Ability to operate efficiently and effectively in a fast-paced environment