embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and X (http://twitter.com/embecta) . 

Why join us?

A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees.

Responsibilities

• Write and maintain procedures required for QMS of embecta G.K.

• Execute processes according to procedures and document execution of the processes. Processes to be assigned include but are not limited to the following:

• Supplier management (including Registered Manufacturing Sites)

• Document & Record Control

• Employee training

• Monitoring of product and processes

• Data analysis

• Internal Audit

• Complaint Handling

• Feedback

• Incoming inspection & Nonconforming material handling

• Product release management

• Change control

• Product incident handling

• Recall Management

• Quality control instruction for distributors

• Directly work with local and global embecta counterparts for day-to-day execution of QMS processes, CAPAs, improvements, and so on.

• Participate in external audits, as needed, for audit preparation, audit response during and after audits.

• Propose and implement changes for the purpose of continuous improvement of the QMS.

• Collect and assess QMS intelligence to take appropriate actions and ensure compliance with up-to-date regulations.

Experience & Education

[Required]

• Education: Minimum of a Bachelor of Science in Engineering or other relevant discipline

• Eperience:More than 2 years’ experience in hands-on execution of QMS processes for medical devices.

[Preferred]

• MAH controller, domestic quality controller, or safety controller for MAH license, or responsible engineer for manufacture license.

• Management Representative for ISO13485/9001 certification.

• Experience with close interactions/partnership with global function and foreign manufacturer.

Knowledge, Skills, and Abilities

• Native level oral and written communication capabilities in Japanese language.

• Business level written communication capabilities in English language.Business level oral communication skill preferred.

• Knowledge of PMD Act, Quality System standards and regulations including QMS Ordinance, and other local regulatory requirements in Japan market.

• Proficiency in use of basic computer skills, such as Microsoft Excel, Word, Powerpoint, etc.

Regular

embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.