Stryker (Suzhou) Medical Technology Co. Ltd
Advertised: 20-02-12 | Closing Date: 21-03-12.
As a broadly based, global leader in medical technology with a tremendous history of success and exceptional growth, Stryker is one of the largest players in the worldwide orthopaedic market and its products improve medical professionals’ and patients’ lives in over 120 countries.
Stryker as a company has been strategically committed to serving the Chinese market for decades, and currently has a technical sales-force of nearly 200 people across 5 offices throughout Mainland China, plus Hong Kong and Taiwan.
In the past years, China’s medical professionals and patients have benefited from Stryker’s leadership in delivering healthcare technologies globally. The 200 The current investment signals a renewed commitment by Stryker to reinforce its participation in the local market, by providing product and talent development both for China and for its worldwide markets. The Suzhou project represents the first manufacturing footprint that Stryker has in Asia.
If you would like to get more information about our company, you can check the company website as
Position Title: (Asso. /Sr.) Supplier Quality Engineer
Department: Asia Supply Development Team (ASDT)
Report To: Supplier Quality Manager, ASDT
Direct Reports: None
The following is not intended to represent all inclusive lists of job representations, but to outline the ESSENTIAL FUNCTIONS of the position.
KEY RESPONSIBILITIES / DUTIES:
Continuously fully comply with all GMP standard /ISO 13485 requirements.
Maintain the local Quality system and implement all quality requirements in the supplier development and supplier quality management areas. Conduct monitoring and trend analysis for Quality System implementation in the supplier management.
Provide guidance on Quality Assurance/GMP/FDA-QSR related topics.
Responsible to stop further processing in the event of encountering non-conforming products condition.
As owners of SNCRs and SCARs, develop, coordinate and/or implement root cause problem solving, preventive and corrective actions. Analyzes reports and/or returned products and recommends corrective action. Ensure timely support to resolve and close supplier related non-conformances.
Set supplier performance monitoring program and quality objectives and makes sure that targets are achieved by monitoring performance/trending against defined parameters.
Conduct external audits and may support internal audits.
Supplier assessments and provide variety of sourcing support activities, including supplier consolidation.
Support Product verification, Process validation, Reliability testing and Component qualification.
Responsible for Supplier process controls, Supplier audit and surveillance.
Drive supplier performance improvements.
Be a focal point of Stryker’s initiative to build a superior supply chain in terms of quality, compliance, cost, innovation and speed to market in Asia.
Work with operational and other functional stakeholders (quality, supply chain, operations, finance) on the screening, qualifying, auditing and supporting of the suppliers for new components, commodities, manufacturing capabilities or assemblies/finished products; on-going relationship management and improvement of supply chain performance.
Ensure that the validated manufacturing processes are adhered to and any changes are communicated in advance and in accordance with our company established standards
Other tasks assigned by Supervisor.
REQUIRED SKILL SET
Energetic, self-initiative and independent individual Demonstrated Collaboration, Negotiation & Conflict Resolution Skills
Fluent in English and Chinese in both technical and business speaking and writing skills.
Demonstrated effectiveness in teamwork and communications with suppliers, supply chain, operations and engineering
Excellent communication and presentation skills in both English and Chinese.
Advanced Quality System and Audit competencies
Preferred knowledge of various Manufacturing Processes (machining, powder coating, metal stamping, forming, plastics and rubber molding, machining, 2ndary processes etc).
Solid understanding of problem-solving processes and tools -6-sigma training and certification and proven ability to apply them a plus
Must be able to observe and note minute inconsistencies.
Must be able to generate, follow, and explain detailed instructions and inspection procedures of the responsible areas accurately.
Familiar with analytical tools, such as FMEA, process control plan and SPC.
Familiar with Blueprint/engineering schematic reading and interpretation
Basic inspection techniques
More than 3 years in Quality Assurance or related functional areas
>5 years relevant experience of supplier development /quality, project management, sourcing in a precision engineering manufacturing environment – medical device industry a plus or equivalent high tech industry.
Experience on working in an environment with multiple projects and varied release cycles. Must have excellent planning, prioritization and organizational skills.
Lead supplier auditor experiences according to regulations, industry quality standards, and internal procedures such as ISO 9000, UL60601, TS 16949, AS9000 and ISO13485 (desired), etc.
Experienced in GMP or ISO quality systems
Experienced in machining inspection, method selection, gauge calibration is preferred.
Bachelor’s degree in Mechanical Engineering, Industrial, Biomedical Engineering or similar fields.