Posted on Oct 12th 2019

Safety& Compliance Manager/Technical Manager

中国,江苏,苏州

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,江苏,苏州

Full time

435225

保存职位

Job Title

Safety& Compliance Manager/Technical Manager

Job Description

In this role, you have the opportunity to

Become part of and grow a team of subject matter experts with passion for bringing the highest quality of electrical (sub)systems and solutions to the Chinese market in compliance with national regulations and standards.

Although your primary responsibilities evolve around the growth and optimization of a modern local EMC lab in Suzhou, you’ll be working in close contact with an international teams of experts to harmonize and optimize local procedures to enable faster time to market of innovative Interventional Guided Therapy systems and solutions.

You’ll work within a multi-disciplinary team on applying research results and technology advancements, while taking care that our systems and solutions (including components, parts, subsystems and integrations with 3rd party devices) complies with the local and international EMC standards, safety & performance standards and (international)  regulations.

You are responsible for

  • Plan, schedule, manage, conduct and support (type approval) tests on IGT (sub)system (e.g., type testing including EMC, Safety & Performance) for assigned projects performing NMPA submissions for initial-, change- and renewal market licenses.
  • Ensure the Suzhou EMC lab receives and maintains CNAS accreditation against the latest ISO 17025, YY and GB-standards. This involves participation in (international) proficiency testing and reporting.
  • Support projects in creating compliant EMC test plans, based on the products technical file and accompanying documentation.
  • Perform EMC tests, collect data and report according to the requirements of the standards and NMPA regulations.
  • Work with different agencies, including NMPA, to support the product certifications, audits and training.
  • Coordinate and work with L4L project team to transfer production of IGT systems and solutions for production and maintenance in China in alignment with the product platform design and architecture requirements.
  • Support the Philips China regulatory team in product submissions and answering (technical) supplementary questions from NMPA.
  • Grow and train the local team in close alignment with the global quality and regulatory teams.
  • Cooperate with Philips laboratories in other geographic regions on harmonization and optimization of the quality management system and standard operating procedures. This includes automation of repetitive tasks and activities to prevent human mistakes.

You are a part of

Quality team Suzhou

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

Minimum Qualifications:

  • Bachelor’s degree or above in Electronics, Electrical or Biomedical Engineering, major in medical or engineering
  • More than 3~5 years experience in EMC testing of medical devices (MD against YY 0505:2012 or equivalent international standards), especially NMPA witness type testing, third-party witness tests or working in (EMC) test laboratories.
  • Familiarity with angiographic X-ray product and EMC product related standards such as: IEC 60601-1 (GB 9706), IEC 60601-1-2 (YY 05050), IEC60601-1-3, IEC60601-2-43, and GB/YY standards.
  • It is preferred to being familiar with China and international standard structures and procedures.
  • Good language skills in writing and speaking in English and Mandarin
  • Excellent communication and interpersonal skill
  • Natural eagerness to take ownership for problem solving and continues improvement
  • Experience in new product introduction and / or life-cycle development in the (medical) industry (Quality and improvement driven)
  • Being a team player with good leadership skills (soft skills)
  • Able to work in cross functional teams
  • Proactive and energetic
  • Hands on and accurate
  • Long-term result driven

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

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