{"id":2232871,"url":"https://alion.io/job/epredia-senior-qms-engineer","title":"Senior QMS Engineer","company":{"id":2520950,"name":"Epredia","domain":"epredia.com","url":"https://alion.io/company/epredia","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Shanghai, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":25000,"max_usd":57000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":6708},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-29T00:00:00Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-12T22:40:22Z","board_verified":true,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"description":"Make a Meaningful Impact\nReady to join a team where your work makes a daily difference in healthcare?\nEpredia 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.\nWe 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.\nJob Title: Sr. QMS Engineer\nWho 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.\nPosition Overview:\nOur values reinforce our culture of collaboration, growth mindset, and how we serve our customers. \n· Responsible for GMP & ISO 13485 compliance for products and processes, drive QMS maintenance & expansion for SSG products to lift customer satisfaction.\nLocation: 上海市浦东新区华东路5001号T6-7\nWhat you will do:\nMaintain & optimize site QMS complying with NMPA GMP, ISO13485 and other applicable regulations for SSG business growth\nConduct QMS activities: management reviews, internal/external audits, document review, cross-functional process mapping\nDraft SOP/WI per regulatory & operational needs, arrange relevant training\nRemediate gaps between current operations and regulatory requirements\nLead CAPA & continuous improvement for QMS nonconformities with cross teams\nDocument control & risk management support\nQualifications & Skills:\nBachelor in engineering/medical related disciplines\n≥3 years medical device QMS experience or equivalent quality management background\nSolid knowledge of NMPA GMP, ISO13485, IVDR, FDA regulations\nStrong cross-team collaboration, fluent English (oral & written), proficient in MS Office\nReady to Make an Impact?\nIf 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.\nBuilding an Inclusive Culture\nWe 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.","description_format":"text","description_chars":2635,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Continuous learning"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Medical Imaging Systems"],"lifecycle":[{"event":"open","at":"2026-10-10T22:18:35Z"}],"visa":[],"liveness":{"score":84,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.839,"p_room":1,"age_days":13,"expected_fill_days":39,"reasons":["conf:3","win:early"],"computed_at":"2026-10-12T06:55:09Z"},"pay":null,"html_url":"https://alion.io/job/epredia-senior-qms-engineer","json_url":"https://alion.io/job/epredia-senior-qms-engineer.json","meta":{"generated_at":"2026-10-13T00:08:30Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":218,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2520950},"rest":"https://alion.io/mcp/rest/get_company?id=2520950"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fepredia-senior-qms-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fepredia-senior-qms-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fepredia-senior-qms-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/epredia-senior-qms-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fepredia-senior-qms-engineer"}]}