招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
Responsible for ensuring that processes needed for the Quality Management System are established, implemented and maintained and assist department head to ensure the promotion of awareness of regulatory and customer requirements throughout the organization. Creates and drives a culture of Quality and Compliance.
?Continuously fully comply with all GMP and Regulatory requirements.
?Responsible to stop further processing in the event of encountering non-conforming products condition.
?Provide guidance on Quality Assurance/GMP/FDA-QSR related topics
?Implement Stryker Corporate Quality policies and standards. Ensure compliance to GMP and ISO requirements
?Ensure sufficient resources supporting Quality system set up and implementation.
?Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
?Defines, specifies, and/or approves of the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products.
?Will train others on GMP, ISO, Quality Assurance/Regulatory Affairs topics.
?Will conduct internal Quality Assurance/Regulatory compliance audits and communicate results.
?Coordinate all external RA/QA audits and corporate audits. Will be the communication channel to interface with external auditing entities and Corporate and communicate results.
?Conduct management reviews and quality reviews and communicate results according to QS requirements. Identify the negative trend and solve issues systematically.
?Leads and implements the Lean philosophy – standardization and elimination of waste.
?Other tasks assigned by supervisor
?Fully authorized to release or Reject product, component, process, and so on according to QS requirements.
SUPERVISORY RESPONSIBILITIES:
?Supervises directly and/or through subordinate supervisors the activities of Quality and Regulatory department.
?Helps to set departmental goals and priorities and evaluates subordinates performance against those goals and priorities.
?Coaches and develops direct report subordinates.
?Is responsible for inter-departmental compliance with company policies and corrective actions
?Must be able to generate and explain detailed proposals, guidelines, and procedures for the RA/QA function to departmental and/or non-departmental personnel.
?Must be able to analyze and resolve non-routine product issues using independent judgment.
?Must be able to routinely make decisions which affect immediate operations and may have a company –wide effect.
?Must be able to promote quality excellence and lead by example
?Excellent analytical skills
?Excellent interpersonal skills
?Demonstrated effective leadership skills
?Excellent organizational skills
RELEVANT EXPERIENCE:
?8+ years in the QA/RA function or equivalent experience
EDUCATION:
?B.S. in engineering, engineering management, or related discipline
?Master degree in engineering is a Plus.
年薪20-30万
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