Quality Assurance and Regulatory Affairs Manager

TSK Laboratory, Japan (TSKJ) is a Japanese family owned company based in Tochigi, Japan that was established in 1973 and employs a total of 200 people. The company has three factories that are specialized in producing specialty needles for the medical, dental, ophthalmology and aesthetic markets.  The company is known for its high quality needles and has a well-established brand name.  Our factories are built to be flexible and to manufacture in small to mid-size production runs on manual, semi-manual and fully automatic production lines.

The company sells worldwide and has a subsidiary in Canada, China and The Netherlands.  TSK Laboratory Europe B.V. (TSKEU) was established in 2010 to manage all sales, marketing and distribution activities in the Europe, Middle East, Russia and Latin America. All global offices work very independently from TSK Laboratory, Japan and they can be considered as stand-alone organizations. TSK Laboratory Europe employs 1 Managing Director, 1 Marketing Manager, 1 Key Account Manager, 1 Controller & System Analyst and 1 Customer Service Manager.

TSK Europe is a small lean organization with a lot of room for individual input and development. All people in the organization are focused on customer service and the QA, RA, CS Rep will help manage all orders and administrative tasks and bring technical, quality assurance and regulatory focus to the team. We are looking for a person to help support our growth across all company functions, manage all customer service related issues and help grow the sales through our distribution and retail channel.  In addition, this person will be responsible to assist with all technical, quality assurance and regulatory documentation for our B2B customers and customers outside the EU

With the primary focus on quality assurance and regulatory affairs, the QA/RA Mgr will also provide support in specific administrative tasks and support our key account with technical, quality assurance and regulatory documentation.  The QA/RA Mgr will provide support in handling emails and all communication between customers, tasks and help to provide accurate quality control and regulatory documentation to key accounts.  A great level of detail and a technical background is required. Good control of the English is required and other languages are a plus.  This position will work closely with the Key Account Manager, Customer Service Manager, and global QA/RA team at the corporate office in Japan.

1. Gain and maintain a good understanding of all quality assurance and regulatory documentation through close cooperation with the corporate quality assurance and regulatory team in Japan.
2. Monitor external changes to the regulatory environment to ensure the continued compliance to the regulatory system.
3. Support customers with regulatory related documents when needed.
4. Review and keep up-to-date all technical customer documentation and contracts.
5. Manage product complaints following our ISO-9001 quality management procedures and identify opportunities to improve product quality.

Knowledge, Skills and Abilities (i.e. minimum education, years of experience, etc.)

1. Quality Assurance and/or Regulatory Affairs responsibilities required.
2. Technical experience is a plus.
3. Minimum of 5 years’ experience in related responsibilities.
4. Bachelor degree (Hogeschool) or equivalent.
5. Fluent in English and conversation level French and German is a plus.
6. Working knowledge of Microsoft WORD, EXCEL and POWERPOINT and the willingness to learn new software. Knowledge in EXACT or other accounting systems a plus.
7. Excellent organizational, interpersonal and analytical skills.
8. Ability to develop close, effective working relationship with customers through email and telephone.

Core Competencies:

1. People Skills – listening, interpersonal, savvy, cooperation and conflict resolution, oral and written communication.
2. Customer Focus Skills – customer service, quality orientation, communicates clearly, concisely, effective and persuasively in writing.
3. Personal Skills – dependability, versatility/flexibility, creativity, action oriented, personal learning, functional and technical knowledge, integrity and trust. Is action oriented and full or energy for the things he/she sees as challenging?

This job description is not intended, and should not be construed, to be an all-inclusive list of all responsibilities, skills, effort, or working conditions as associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserve the right to modify, add or remove from particular jobs and to assign other duties necessary.