Complianace Specialist III
Philips
Alajuela
hace 5 días

Job Description

In this role, you have the opportunity to

Assures compliance in accordance with procedures and applicable federal regulations and international standards while ensuring the execution of department goals and objectives.

The Quality Compliance Site Specialist 3 will contribute to Philips's success by participating and managing the activities of the corporate CAPA, internal audit program, NCR, and site compliance programs including external audits.

You are responsible for

Review and provide guidance to CAPA and Internal audit observation owners for the improvement of Systemic Gaps on the organization and perform the QA compliance revision of these records.

Provide training on root cause investigation tools, effectiveness verification and determination of the risk to CAPA and Internal audit observation owners.

Act as a leader external audits preparation and participate on the execution as part of backroom or frontroom.

Lead CAPA review meetings and prepare Management Review meetings.

Manage or participate in the internal audit program including execution of the schedule on time and training of auditors.

Additional functions may be essential as designated by the Supervisor

You are a part of

A leading health technology company with a multinational workforce of approximately 77,000 employees and globally present with sales and services in more than 100 countries worldwide.

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

EDUCATION :

  • Requires a bachelor’s degree in related field or equivalent training .
  • Adequate combination of educational background and / or experience in Medical Companies to effectively perform self training.
  • 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
  • Successful completion of a recognized Lead Auditor course.
  • KNOWLEDGE AND EXPERIENCE :

  • Root cause investigations training or experience.
  • MDSAP Model understanding.
  • QA system software configuration and administration experience / education.
  • 5+ years of experience in a medical device, biologics or Pharma industry.
  • Working knowledge of appropriate global medical device regulations, Requirements, and standards, such as 21 CFR Part 820, ISO13485, ISO14971, European Medical Device Directive (93 / 42 / EEC) and EUMDR, Canadian Medical Devices Regulation (SOR / 98-
  • 282), Japanese MHLW Ordinance 169, and ISO 9001.

  • Audit experience.
  • Strong CAPA knowledge and experience.
  • 90% English (reading and writing.
  • In return, we offer you

    In order to develop your full potential, we will offer you the flexibility, encouragement and opportunities to keep you inspired and engaged.

    After all, working at Philips is more than a job. It is an experience full of amazing moments that will transform you in a lasting and positive way, since together we can improve the world.

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