Haemonetics Quality Assurance Manager in Tokyo, Japan

Title: Quality Assurance Manager

Location: Japan-Tokyo Metropolis-Tokyo

Job Number: 161111536

Summary:
The Quality Manager is responsible for effective implementation, execution and maintenance of Quality Management Systems (QMS) and compliance programs . The Quality Manager will ensure compliance of the respective QMS through a process of monitoring (audit) and training, effective change control and effective communication of compliance requirements.
Principal Responsibilities:

Oversees Quality Management System compliance through the effective deployment of the internal audit program, CAPA program, NCE process, Management Review activities, quality meetings and routine trend analysis of key performance indicators for processes. Establishes and maintains controls of the QMS.

Implements and maintains Corporate quality standards and ensures organizational compliance with Quality Systems procedures and regulations.

Provides training support to ensure that internal constituents understand the requirements of the QMS regulations and their responsibilities to the QMS.

Works through individual contributors or supervisors, ensures the effective implementation and maintenance for Quality Systems requirements.

Ensures organizational compliance with Quality Systems procedures and regulations.

Adheres to and follows Haemonetics policies and procedures and applies function related SOX requirements.

Partners with all involved parties providing solutions with quality guidance and regulatory compliance.

Partners with all involved parties to integrate design and engineering change to processes and product through a quality plan including verification and validation.

Partners with all involved parties to pro-actively identify and resolve quality issues and ensures products are delivered and supported in compliance with written specifications.

Regularly monitors the status of corrective actions/preventive actions to ensure quality issues are resolved and products remain in compliance with written specifications.

Promotes and educates personnel on quality system requirements, responsibility, and accountability.

Represents Haemonetics in 2nd (e.g. customer, contractor) and 3rd

party quality system audits.



Qualifications:
Candidate Education:
Required

Bachelor's Degree

Quality/Engineering or Life Science discipline
Candidate Experience:
Required

5 years

Related Quality Systems experience
Preferred

Other

Medical device experience
Preferred

Other

Software design experience
Candidate Skills:
Licenses and Certifications:
Preferred

lead auditor qualified
Preferred

expertise in using concepts such as Six Sigma and lean business process
Candidate Background: Skills, Knowledge & Ability: Minimum requirements:
Required

Related Quality Systems experience
Preferred

Medical device experience
Preferred

Software design experience

Job: Quality