Quality Consultant (Japanese Speaker)
Job Description – Quality Consultant (Japanese Speaker)
Role: Quality Consultant (Japanese Speaker) - Full Time
Date: Immediate start
Contract duration: 6 months
About Trinzo:
Trinzo is a Medical Device and Pharmaceutical consultancy firm based in Galway, Ireland that specializes in providing our clients, who are Global Leaders in the Medical Device and Pharmaceutical Industry with Quality, Compliance, Regulatory and Project Management experts.
Trinzo’s Core Values:
- High performance.
- Value focused.
- Teamwork/collaboration.
- Positive, can-do attitude.
- Gratitude and humility.
- Trusting.
Our client a well known medical device company are seeking a Quality Consultant to support their team on working through a large volume of open CAPA’s.
Responsibilities:
- Execution and coaching CAPA owners on High risk CAPA from problem statement to root cause investigation to action implementation for effective verification in a timely manner
- Closing of urgent CAPA’s in line with standards while maintaining a high level of quality throughout
- Robust investigation and action planning activities.
- Actively participate in continuous improvement initiatives.
- Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.
- Identify gaps in quality systems and develop feasible plans for correction.
- Identifies problems and generates alternatives and recommendations.
Role Requirements:
- A minimum of 5 years’ experience in Medical Device industry.
- A Bachelor’s Degree or equivalent in biomedical engineering, science, healthcare, or medical profession
- Advanced understanding and execution of CAPA’s previously, as well as global medical device regulations, requirements, and standards
- Prior experience with companies dealing with 483 warning letters.
- Excellent Verbal and written communication skills.
- Analytical skills and focus on detail.
- Ability to work as a team towards urgent goals
- Fluent in Japanese and English (verbal and written).
- Locations
- Japan
- Remote status
- Hybrid Remote
Japan
Our Company Culture
People First, Always
Trinzo is a company driven by unshakeable core values: we put people first, from our consultants to our clients, and we value hard work, honesty and integrity above all.
At Trinzo, we strive to create a company culture that encourages each member of the consultancy ecosystem to reach their fullest potential, whether that’s a client with an organizational issue or a consultant with a vision for change.
We help our team to lead the industry in creating solutions, applying well-tested methodologies and persistently seeking innovative ways to help our clients succeed.
About Trinzo
Trinzo is a medical device and pharmaceutical consultancy firm that excels at compliance, regulatory and project management issues. We create bespoke solutions for our clients on a project basis and find the root of structural issues.
In many cases, our clients hire us to solve a specific problem or remediate an issue. Sometimes, the issue at hand is only surface-level and our knowledgeable consultants use their industry expertise to design a comprehensive solution. But when the challenges run deeper, Trinzo will get to the heart of the issue, offering insight, advice and industry-leading methodologies that will leave your team stronger, with renewed motivation and increased efficiency.
Quality Consultant (Japanese Speaker)
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