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
#LI-FP2
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.
Skills Required
- Bachelor’s degree in engineering or a medical-related discipline
- At least 3 years of medical device QMS experience or equivalent quality management experience
- Knowledge of NMPA GMP, ISO 13485, IVDR, and FDA regulations
- Strong cross-functional collaboration skills
- Fluent English communication skills, oral and written
- Proficiency in Microsoft Office
What We Do
Every second of every hour of every day, 44 of our products are employed in the battle against cancer. Customers put their trust in Epredia over a billion times every year. Epredia was established in July 2019 through an acquisition by PHC Group from Thermo Fisher Scientific. Powered by trusted brands such as Shandon, Microm, Menzel Gläser and Richard-Allan Scientific, Epredia has a wide breadth of solutions that have and will continue to transform the anatomical pathology market. Today, we’re a global precision cancer diagnostics company working to improve patient outcomes by providing groundbreaking technologies. Since our humble beginnings in 1937, every product developed has been impacted by generations of employees who are committed to improving lives by enabling pathologists through enhancing precision cancer diagnostics. Find out how you can improve lives while advancing your career at #Epredia by visiting epredia.com/careers. #WhatWeDoMatters
