高级质量体系工程师

Posted 16 Nov 2022

Wuxi, Jiangsu - China

Req Id 258160

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 352 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:
1.    Routine Operations R&R:
1.    Overall manage, optimize, and review site quality systems, including but not limited to quality risk management, change control management, deviation management etc. 
2.    In charge of build-up site quality manual, monthly quality management review and annually quality system review, to ensure the effectiveness of quality system meet with business requirements.
3.    In charge of participation and implementation of self-inspection, internal audit, and customer activities. Ensures that audits are performed per developed schedule. Review findings and makes recommendations for findings. Ensures timely response and closure of all action items / commitments.
4.    In charge of supplier quality management implementation which covers supplier/contractor audit, quality oversight of suppliers and contractors, quality & technical agreement with suppliers etc.  And cooperate closely with global and peer site supplier management team to ensure the effective and efficient supplier management.
5.    Support on site quality KPIs and performance monitoring and Quality governance structure to maintain the process of management review and report the quality relevant metrics team with APAC quality. 
6.    Ensure site quality system related documents aligned with ISO9001 standard and LSQ policy and procedure requirements.
7.    Responsible for facilitation of Annual Quality System Review activities such as risk register and Integration management review.
8.    Additional tasks assigned by line manager, as necessary.
2.    R&R on Compliance:
1.    Strictly follow regulationSOP requirements, execute the operations with GMP common sense, fulfill Data Integrity requirements every time, all the time.
2.    Point out the activities or issues which is not compliance, report to manager in timely manner.
Who you are:
1.    BS in Pharmaceutical, Science or equivalent. 
2.    6+ years quality management experience in pharmaceutical, medical device, or life science industry. 
3.    Excellent communication, problem-solving, planning and organization skills 
4.    Fluent in English, both of written and oral.
HR: 95989
Functional Area: Quality
 


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!


Careers during Covid-19

Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

North America Disclosure

The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

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