长沙招聘

Business Segment

Healthcare Quality

About Us

N/A

Role Summary/Purpose

A QA Senior Site Leader is responsible for ensuring quality and regulatory compliance of a large and/or multi-modality facility and/or covers multiple sites, while driving process effectiveness and efficiency. The QA Senior Site 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 require-ments 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.

• Ensuring site audit readiness and 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.

Qualifications/Requirements

Qualifications:

1. Bachelor's degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 10 years work experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment environment).

2. Minimum 5 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry.

3. Minimum 3 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

Desired Characteristics

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.

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。