南京招聘

Business Segment

Healthcare Quality

About Us

N/A

Role Summary/Purpose

A Site Quality Leader is responsible for ensuring quality and regulatory compliance of the facility, while driving process effectiveness and efficiency. The Site Quality Leader represents GE Healthcare to external agencies and champions the evolution of the quality culture for the site.

Essential Responsibilities

• Directing the Site Quality Management System, fully integrated into the GE Global Quality Management System, including cross-functional and site-specific processes. The role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organization.

• Maintaining and improving all aspects of Site Quality Planning.

• Overseeing all Quality-related communications and training requirements for all site employees

• Establishing positive relationships with outside agencies.

• Hosting Quality System audits and inspections. • Overseeing the Corrective Action / Preventive Action activities and Complaint Handling Programs, and in some cases, Quality Engineering.

• Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.

• Driving the definition of site quality objectives, metrics, reporting and operating mechanisms.

• Participating in selected global initiatives to share best practices and leverage quality synergies.

• Supporting local R&D programs and quality issue resolution.

• Acting as Management Representative for Quality at the Site.

• Operates a Local Inspection program and manages f/up activities to close NCs.

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. Maintain full Quality System Regulations and Current Good Manufacturing Practices Requirements ensuring compliance to regulations and legal requirements through successful and effective quality management systems.

5. Identify and ensure timely closure of corrective and preventive actions for the site.

6. Participate and represent the Site in external Audits.

7. Mentor and coach direct reports to successful understanding and implementation of Quality System Requirements.8. Timely communication of all quality concerns, initiatives, and information to the site Management team.

9. Meet specific quality metrics and/or milestones as defined in annual business objectives.

Qualifications/Requirements

Qualifications:

1. Bachelor's degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 7 years work experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment environment).

2. Minimum 3 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry.

3. Minimum 1 years supervisory/ management experience, including hiring, training, coaching and performance management activities.

4. Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.

5. Proven track record in performing external and internal audits.

6. Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.

7. Effective report, business correspondence and procedure writing skills.

8. Good problem identification, multivariable analysis and creative resolution aptitude.

9. Proven process development and project management skills.

10. Strong computer skills. 11. Ability to communicate using English.

Preferred Qualifications:

1. Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.

2. Experience in a global, matrixed organization structure.

3. Professional certification as a Lead Auditor.

4. Six Sigma training and/or certification.

5. Team player with a global mindset.

6. Strong Change Acceleration skills.

7. Experience in building a Quality System from ground up.

8. Front line operational responsibility in Engineering, Manufacturing or Sourcing.

Desired Characteristics N/A

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。