Quality System Manager ISO品質系統 經理-TC21152

工作内容

[Summary]

The MS Manager will provide leadership in the implementation, maintenance, and improvement of company-wide Management System (MS) in compliance with applicable regulations, requirements and standards. Proactively monitors the various elements of the MS to help ensure compliance with ISO standards, EHS, RBA, and/or any applicable regulatory requirements. Promotes quality achievements and performance improvements throughout the organization.

This position will play a key role and responsible for maintenance of the MS, including planning and coordinating the internal audit and external / 3rd party audits.

This position works directly with multiple teams to support the development and implementation of a proactive MS based on the business needs and goals. This includes the creation, training, deployment, auditing, and maintenance of the global MS as required to maintain compliance with ISO standards (e.g. ISO 9001, 13485, 14001, 27001, etc.) and company specific requirements

[Requirement]

• Must have a Bachelor Degree, preferable in the Science / Engineering.

• Prior experience in leading QMS, QMS and/or EHS audits in the manufacturing, pharmaceutical, medical device, or similar industries.

• Must be proficient in technical writing and have excellent communication skills (articulate and persuasive).

• Ability to work independently in a fast-paced environment.

• Strong team management and leadership skills. Ability to create strategies, define and articulate clear role expectations and direction. Willingness to “do what it takes,” including direct auditing activities at times

• Previous experience in computer industry with established QMS, EMS, and/or (ISO 9001, ISO14001, ISO13485, 27001, etc.) including CAPA, Internal Audits, Training, Nonconformity, or • Must have a Bachelor Degree, preferable in the Science / Engineering.

• Prior experience in leading QMS, QMS and/or EHS audits in the manufacturing, pharmaceutical, medical device, or similar industries.

• Must be proficient in technical writing and have excellent communication skills (articulate and persuasive).