Philips Sr. Q&R Compliance Lead in Haifa, Israel

We are looking for a Q&R Compliance Sr. Lead 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.

This position helps define, interpret, and/or ensure the use of, and compliance to, appropriate standards and regulatory requirements.

Responsibilities:

  • Supports the implementation of the Business’ long-range quality, regulatory and compliance policy.

  • Creates Q&R awareness level as determined within the organization.

  • Enforces (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.

  • Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.

  • Assists 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.

Requirements:

  • 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.

We are looking for a Sr. Q&R Compliance Lead 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.

Your Responsibilities​

  • 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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .