- Maintains the company Quality Management System processes and procedures required to manage product and regulatory requirements
- Stays current with industry regulations and standards including NMPA and ISO 13485
- Maintains site training program for quality system
- Manages the company document and records control processes
- Completes internal audits according to the company's internal audit program
- Manages the company corrective action (CAPA) program
- Assists in scheduling yearly Management Review and in compiling management review data
- Assists with Change Management process across multiple sites
- Coordinate and prepare site audit from health authority, notified body and key customers
- Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area
- Accurately records and reports of information as required
- Follows employee policy within the company
- Other duties may be assigned, directed or requested.
- Must have 3+ years quality assurance (quality system) experience in medical device manufacturing field.
- Bachelor's degree in engineering and/or manufacturing fields preferred
- Familiarity with NMPA medical device regulations and ISO13485:2016
- Must be able to utilize the basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts
- Must be able to produce technical documents, such as draft management review, KPIs at defined timeline, risk management for the quality system and formal procedures / work instruction
- Support / assist other departments than quality for investigation, collecting metrics
- Must have good oral and written communication skills
- Must have basic computer skills (Microsoft Office)
- Experience in make-to-order and make-to-stock manufacturing.
- Familiarity with FDA and other International medical device regulations
- Internal Auditor certification is preferred
- Six Sigma/Lean Manufacturing skills preferred.
- Process Validation/Software Validation experience
-
On Shanghai, 中国 全职Team for Career Site · Customer Service · In short · This is your opportunity to join one of the world's fastest-growing sports brands in a position of real scope and high impact At On, we have recently implemented a new ERP (enterprise resource planning) system that enables our ...
-
Mercedes-Benz Shanghai, 中国Tätigkeitsbereich:Forschung & Entwicklung incl. DesignFachabteilung:System ArchitectGesellschaft:Mercedes-Benz Group China Ltd.Standort:Shanghai, CNStartdatum:sofortVeröffentlichungsdatum:..4Stellennummer:MERII Join usAufgaben · Design MB next generation Parking System on active ...
-
Continental Shanghai, 中国 全职Job Description · [Continental Tires] · Play a key role in design, implementation and production support of all responsible systems. · Complete the key module of business system, provide effective and innovative IT solutions to enable the business capabilities and solve the · b ...
-
SBM Offshore Shanghai, 中国Our Vision. · SBM Offshore believes the oceans will provide the world with safe, sustainable and affordable energy for generations to come. We share our experience to make it happen. · Our Profile. · We design, build, install and operate offshore floating facilities for the offsh ...
-
ICSS Specialist
2天前
SBM Offshore Shanghai, 中国Our Vision. · SBM Offshore believes the oceans will provide the world with safe, sustainable and affordable energy for generations to come. We share our experience to make it happen. · Our Profile. · We design, build, install and operate offshore floating facilities for the offsh ...
-
Accountant
5天前
OIA Global Shanghai, 中国1. Input and update the accounts payable data of all branches into the financial system according to the company's relevant procedures (including but not limited to CARGOWISE ONE, Yonyou and WORKDAY to be launched soon), among which CARGOWISE ONE and WORKDAY are all English syste ...
-
AsstrA Shanghai, 中国· Sales Support Specialist at AsstrA | softgarden · View job here Sales Support Specialist · Full Time · Shanghai, China · Without Professional Experience · 11/23/23 · Sales Support Specialist · AsstrA is an ambitious team of 24 countries. More than 1,400 employees work in Eur ...
-
Sales Specialist
4天前
ABB Shanghai, 中国 OTHERSales Specialist · Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. · At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gende ...
-
ABB Shanghai, 中国 OTHERDigital Sales Specialist · Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. · At ABB, we have the clear goal of driving diversity and inclusion across all dimension ...
-
Beijing Century Joyo Courier Service Co., Ltd. Shanghai, 中国 全职· Amazon strives to be Earth's most customer-centric company where people can find and discover virtually anything they want to buy online. To serve the goal, Amazon has created one of the most advanced fulfillment and logistic networks in the world. · Amazon Global Logistics i ...
-
On Shanghai, 中国 全职Team for Career Site · Retail (office team) · In short · Do you have what it takes to bring our new store opening projects in the APAC region to the finish line through planning, preparation and procurement up to the actual execution of onsite tech installations? · If you ever wa ...
-
Sealed Air Corporation Shanghai, 中国SEE designs and delivers packaging solutions that protect essential goods transported worldwide, preserve food, enable e-commerce and digital connectivity, and help create a global supply chain that is touchless, safer, less wasteful, and more resilient. · SEE strives to foster a ...
-
Virtuos Shanghai, 中国PLAY, GROW and WIN · To be a part of Virtuos means to be a creator and aim atexcellence. · At Virtuos, we harness the latest technologies to make videogames better and more immersive than ever before. That is why we prideourselves in constantly pushing the boundaries of possibil ...
-
On Shanghai, 中国 全职Team for Career Site · Technology · In short · Do you have what it takes to bring our new store-opening projects in the APAC region to the · finish line through planning, preparation and procurement up to the actual execution of onsite · tech installations? · If you ever wanted t ...
-
Steel Logistics
1周前
AsstrA Shanghai, 中国· AsstrA Steel Logistics - Sales Specialist at AsstrA | softgarden · View job here AsstrA Steel Logistics - Sales Specialist · Full Time · Shanghai, China · With Professional Experience · 11/23/23 · Sales Specialist · AsstrA is an ambitious team of 24 countries. More than 1,40 ...
-
HSE Specialist
5天前
ABB Shanghai, 中国 OTHERHSE Specialist (职业健康安全与环保专员) · Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. · At ABB, we have the clear goal of driving diversity and inclusion across all dimen ...
-
Beijing Century Joyo Courier Service Co., Ltd. Shanghai, 中国 全职· Amazon strives to be Earth's most customer-centric company where people can find and discover virtually anything they want to buy online. To serve the goal, Amazon has created one of the most advanced fulfillment and logistic networks in the world. · Amazon Global Logistics i ...
-
Johnson Matthey Shanghai, 中国Time served engineer/technician (typically apprenticed). Specific technical skills such as PLC control, programming (robots, multi-axis CNCs etc.), specialist fabrication etc. Operates more complex and more technically demanding processes. Focuses on daily and weekly activities. ...
-
ARRK Engineering Co. (Shanghai) Ltd. Shanghai, 中国 全职YOUR RESPONSIBILITIES · Prepare and organize vehicles, installing and setting-up the measurement technology for test driving · Do a brief pre-analysis of functional and system errors · Perform test drives as part of the Level 3 functional development ADAS Team home and abroad · ...
-
Extron Shanghai, 中国Office: Extron China · Location: Shanghai, China · Department: Sales · # of Openings: 1 · CUSTOMER SUPPORT SPECIALIST General Responsibilities: · Provide Excellent Customer Service · Handle all Customer Service related calls · Know who and when to transfer a call · Technical k ...
Senior Quality System Specialist - Shanghai, 中国 - Straumann
描述
Position Summary
This role is responsible for maintaining SMCN's Quality Management System by ensuring company procedures comply with regulatory and ISO requirements. Responsible for the administration of quality policies and procedures.
Job Responsibilities
This position is responsible for, but not limited to, the following:
Qualifications
Desired Qualifications
 Ltd.&v=024){kind=logo}
