We are looking for a Sr. Q&R Compliance Specialist to ensure and maintain compliance across the organization in compliance with applicable standards and regulatory requirements and support an effective QMS is maintained in scope.
In this role, you have the opportunity to
Help define, interpret, and/or ensure the use of, and compliance to, appropriate standards and regulatory requirements.
Support the implementation of the Business’ long-range quality, regulatory and compliance policy.
Create Q&R awareness level as determined within the organization.
Enforce (a simplified) quality system and harmonizes it across the Business
Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
Manage compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
Assist organizational units in addressing compliance deficiencies.
May also provide other compliance support, including reviewing responses to audit findings for completeness and effectiveness and providing training on key compliance topics.
To succeed in this role, you should have the following skills and experience
Bachelor of Science or equivalent in technical/ engineering or clinical field.
At least 4 years professional work experience with medical device regulations and standards (specifically, US FDA QSR, EU MDD, Canadian CMDCAS, Japan PAL regulation and other WW regulations and standards).
Experience and knowledge in production activities and production floors of medical / pharmaceutical firms.
Experience with business-related implementation projects, including being an active leader/contributor on projects with scheduled deliverables.
Certified ISO 13485 lead auditor – An advantage.
Fluent verbal and written English.
Good communication skills and convinced team player.
Attention to detail and self-directed
Able to learn new topics quickly.
Able to perform assignments in an accurate, timely, thorough and structured manner.
Good time management, prioritization and multi-tasking.
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.
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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