宜昌招聘

JOB TITLE: Principle/Sr. Quality Specialist (new initiative project)

REPORTS TO: Associate QA Director

DEPARTMENT: QA/RA

MAIN PURPOSE OF JOB (BRIEF SUMMARY)

Provide quality support to new initiative projects , including quality assessment, due diligence, facility set up and QMS set up, QMS improvement etc.

MAIN JOB DUTIES/RESPONSIBILITIES (Please list most important duties first)

• Provide regulatory and quality assessment to new initiative projects of MITG and other BUs per different business purpose and timeline, including pre-assessment, due diligence, training and so on. ( Major focus)

• Provide quality supportive and/or consultative work to related localization project from business plan phase to GMP certification. ( Major Focus )

• Participant the related projects with local authorities base on different projects as quality expert. ( Major focus )

• Other tasks assigned by line manager

• May work in different location during project period and frequent travel ( about 30-50%)

  JOB QUALIFICATIONS

REQUIREMENTS

1. Bachelor Degree of University or above, with related majors

2. In depth knowledge of technology and quality control on medical device / pharmaceutical

3. Solid understanding on Medical GMP/GSP and ISO13485

4. Familiar with PDP process of medical device or pharm is prefer

5. Familiar with EU & US medical device regulations is prefer

6. With the certificate of Green Belt or Black Belt is prefer

7. Medical, pharmaceutical background

8. Good knowledge of risk management & project management

9. Prefer familiar with local authorities working approach on projects

JOB EXPERIENCE

1. Min. 7-10 years of experience with quality or manufacture or project in a medical device or pharmaceutical company

2. Prefer working experience in global pharmaceutical/medical device company

3. Quality experience in medical device, pharmaceuticals or electronics or software

4. Familiar with manufacture process, facility& utility , laboratory and/or product design work,

5. Familiar with authorities projects working process

SKILLS / COMPETENCIES

1.Fluent English in both oral and written communication

2.Excellent logical thinking

3. Good Team work and influence in cross-function

4.Good leadership & management skill in project team ( external and internal)

5. Good Presentation Skills

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.