Quality Manager - Manufacturing

COMPANY PROFILE

§  Business type: 100% investment from Japan

§  Established in Vietnam: January 2013

 

GENERAL INFORMATION

§  Position: QUALITY MANAGER - MANUFACTURING

§  Job code: JO-170829-135287

§  Level: Manager

§  Contract term: Permanent

§  Recruitment reason: New-hired

§  Expected joining date: Pursuant to Vietnam Labor Law

§  Work location: Dong Nai

§  Work time:                     Monday - Friday (8:00am - 5:00pm)

Saturday (8:00am - 5:00pm, off twice per month)

§  Salary range: Negotiable based on candidate’s capability

 

JOB DUTIES

§  Job Responsibilities:

-          QMS areas of ownership, management and responsibility may include CAPA, Audit (internal, external, supplier), Post Market Surveillance (recalls / field actions, product risk review, post-market data review), Quality System Training, Document Control, Management Review…

-          Serve as expert and main point of contact for regulatory / compliance issues within area of responsibility

-          Act as policy / procedure owner for area(s) of responsibility; ensure that they are compliant and effective 

-          Execute their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations, which likely include generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance

-          Monitor the health of QMS areas(s) within responsibility and provide metrics to management as required including any governing oversight boards

-          Identify and implement continuous improvement opportunities within their area(s) of responsibility

-          Serve as Subject Matter Expert and Process Owner for their QMS area(s) of responsibility during audits and inspections

-          Influence the organization on quality objectives, prioritization and resourcing decisions

-          Manage and provide operational leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives

-          Act as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on global projects

-          During audits and inspections, interface with global regulatory authority, notified body auditors and provide general support for the Quality group

 

JOB REQUIREMENTS

§  Desirable Background and Experience:

-          Qualification: Bachelor Degree in related fields

-          Language skill(s): English fluent

-          Computing: MS Office proficiency

-          Minimum 5 years of experience on Quality Assurance and/or Regulatory Affairs, involved in US FDA Class II or Class III medical devices with good knowledge about applying global device laws and regulations for adverse event reporting and product recalls

-          Preferred training in US and international medical device regulations and standards (FDA, CFR 820, MDD, ISO 13485)

§  Desirable Characters:

-          Gender: Any

-          Age: Around 40-50s

-          Personality: strong, studious, resourceful, good interpersonal skills

-          Demonstrated ability to lead people and get results through others

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