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Quality & Regulatory Manager, Health Systems

Philips
Jakarta, JK
17 days ago: Philips

Job Description

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You are responsible for

  • Support and maintain the local/regional Quality Management System(s) (policies, procedures, work instructions), with revisions and implementations of new regional policies and processes.

  • Assist and participate in local/regional internal audits as well as observing and assisting in the preparation for L2 audits.

  • Ensure the CAPA is closed on time; provide assistance as and when is expected from stakeholders.

  • Maintain APAC/ASEAN/Local Quality Management System (policies, procedures, work instructions)

  • Assist and ensure quality initiative projects with investigation and data collection.

  • Administrator for document control system by processing quality documents for control and approvals.

  • Administrator and driving completion for Training Management System.

  • Review and ensure the completion of customer feedback and complaints between market and BIU.

  • Coordination with Business Unit Q&R on the deliverables and perform gap analysis, preparation/review of document packages (CSDT) or the pre-market regulatory submissions locally and if required, regionally.

  • Prepares/review and submits Field Corrective Action reports and adverse event reports to the local competent authority, ensure the closure is obtain from the competent authority, if required, including any additional communications to local competent authority.

To succeed in this role, you should have the following skills and experience

  • Minimum Bachelor’s Degree in Engineering, ideally with at least 5 years of experience in Quality and/or Regulatory Affairs.

  • Proficiency in the use of Microsoft Access and Excel is an advantage.

  • Strong interpersonal skills in the areas of verbal and written communication, telephone courtesy and professionalism.

  • Strong organizational skills and take initiatives.

  • Problem solver, attention to detail and the ability to maintain confidentiality of product registration documents.

  • Must be a team player and capable of working with minimal supervision.

  • Must be able to set goals and accomplish them within set time schedule and budget.

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/Philips Chronic Disease_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 .


null You are responsible for Support and maintain the local/regional Quality Management System(s) (policies, procedures, work instructions), with revisions and implementations of new regional policies and processes. Assist and participate in local/regional internal audits as well as observing and assisting in the preparation for L2 audits. Ensure the CAPA is closed on time; provide assistance as and when is expected from stakeholders. Maintain APAC/ASEAN/Local Quality Management System (policies, procedures, work instructions) Assist and ensure quality initiative projects with investigation and data collection. Administrator for document control system by processing quality documents for control and approvals. Administrator and driving completion for Training...