Senior QMS Engineer

Make a Meaningful Impact

Ready to join a team where your work makes a daily difference in healthcare?

Epredia is a global leader in precision cancer diagnostics solutions. In fact, every second, our products are used 48 times in labs and medical facilities around the world.

We are a proud member of PHC Group, a global collection of companies committed to delivering precision technology for the future of healthcare, from specialized medical equipment to health IT systems to research tools.

Job Title: Sr. QMS Engineer

Who you are: You have energy and drive in abundance, a passion for serving our customers and possess a growth mindset and love of continuous learning, with an appreciation for diverse perspectives and helping others win. 

Position Overview:

Our values reinforce our culture of collaboration, growth mindset, and how we serve our customers. 

·              Responsible for GMP & ISO 13485 compliance for products and processes, drive QMS maintenance & expansion for SSG products to lift customer satisfaction.

Location: 上海市浦东新区华东路5001号T6-7

What you will do:

• Maintain & optimize site QMS complying with NMPA GMP, ISO13485 and other applicable regulations for SSG business growth
• Conduct QMS activities: management reviews, internal/external audits, document review, cross-functional process mapping
• Draft SOP/WI per regulatory & operational needs, arrange relevant training
• Remediate gaps between current operations and regulatory requirements
• Lead CAPA & continuous improvement for QMS nonconformities with cross teams
• Document control & risk management support

Qualifications & Skills:

• Bachelor in engineering/medical related disciplines
• ≥3 years medical device QMS experience or equivalent quality management background
• Solid knowledge of NMPA GMP, ISO13485, IVDR, FDA regulations
• Strong cross-team collaboration, fluent English (oral & written), proficient in MS Office

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Ready to Make an Impact?

If this opportunity aligns with your skills and career goals, we'd love to hear from you. Apply today and take the next step in your career with us.

Building an Inclusive Culture

We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information, or any other protected classes which may exist under applicable federal, state, or local law.