Function:
IT & Engineering
IT & Engineering
Industry:
Pharmaceutical
Pharmaceutical
Monthly Salary:
Negotiable
Negotiable
Company Description
Our client is a reputable medical device multinational company with global operation, strong supply chain, and international presence; offer the reliability and efficiency that fit customers need.
Job Description
This role of Quality Manager - Medical Device is critical to leading and managing the global company quality standard.
Responsibilities
- Lead and manage the deployment of corporate quality engineering effort and plans are align with the Company business goals
- Lead the quality team to align the company quality standard
- Work close with internal parties such as design, engineering, manufacturing operations, and other cross functional stakeholders to ensure quality considerations are taken into account at every stage of product lifecycle.
- Develop and implement quality assurance plan for medical device compliance, regularly review and update to adopt any changes in the market.
- Ensure strict implementation of SOPs.
- Provide quality engineering guidance for product development and modification to stay updated on industry best practices.
- Lead and manage customer inquiries, incidents/ root cause analysis, and complaint follow-up.
- Perform product design review, risk analysis, and design validation to mitigate potential risks and identify potential issues.
Requirements
- Degree or above in engineering, bio-medical or health science
- Minimum 10 years of experience in medical device's quality, regulatory affairs, manufacturing, or engineering.
- Good understanding of US, EU medical regulations and international industry standards.
- Hands-on application of statistical methods, process control, quality management system implementation and data analysis.
- Preferred Certified Quality Professional or medical device QMS internal auditor.
- Result-oriented, initivative, able to work independently and with strong communication skills.
- Ability to work cross functionally.
- Willing to travel.
Our client offers fringe benefits and competitive remuneration package to the right candidate.
Please email your resume to hello@adventusource.com
Please email your resume to hello@adventusource.com
