长沙招聘

It's Contractor Role.

Description:

The QA Specialist is responsible for leading the development and maintenance of Quality System metrics, reporting and operating mechanisms to help drive the site quality objectives.

Key responsibilities include:

·       Leading the development and maintenance of Quality System metrics, including but not limited to:

？  Complaint Metrics

？  CAPA Metrics

？  MDR/C&R Metrics

？  Audit Metrics

？  Production and Process Control Metrics

？  Training Metrics

？  Purchasing Metrics

？  Design Control Metrics

·       Supporting the preparation and execution of Quality Management Reviews at the site and P&L &GEHC levels

Quality Specific Goals:

1.     Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

2.     Complete all planned Quality & Compliance training within the defined deadlines

3.     Identify and report any quality or compliance concerns and take immediate corrective action as required

4.     Ensure on-time reporting of the metrics for quality management reviews

5.     Ensure 100% execution on specific QMR action items related to metric establishment and reporting

Qualifications:

1.     B.S. Degree in business or technical field.

2.     1 year experience in a medical device or pharmaceutical industry.

3.     1 year experience with CA/PA systems, including complaint handling.

4.     1 year experience applying regulations (including FDA QSRs, ISO13485).

5.     Proficient with MS Office word processing, spreadsheet, presentation, and database applications.

6.     Ability to identify root cause of problem, and creatively problem solve to gain resolution.

7.     Ability to communicate effectively in English (both written and oral).

8.     Ability to work independently in fast-paced environment with little supervision.

9.     Ability to adapt to constant change and influence positive change effectively.

10.  Team-oriented and responsive to customer needs.

11.  Quality-Focused, Attentive to Detail and Results-Oriented.

Preferred Qualifications:

1.     Statistics education and or training

2.     Experience developing and tracking quality metrics

3.     Familiar with Continuous Improvement methodologies, including Six Sigma

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。