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部署・役職名 | Quality Engineer |
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仕事内容 |
Job Description Quality Engineer This position provides an opportunity to transition from other private, public, government or military experience to a 3M career. The Impact You’ll Make in this Role As a Quality Assurance Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Leading the Quality Assurance for Product Segment of Japan by providing expert-level Quality function leadership, guidance, for post-production quality assurance programs, policies, processes, procedures and controls for medical devices Identifying and leading improvement opportunities to proactively ensure compliance to all applicable internal, domestic, and international quality regulations and competent authority requirements, including but not limited to, ISO 13485, ISO 14971, PMDA Partnering with the Supply Chain and Marketing & Sales organizations to define and implement effective programs and oversight to drive quality and compliance, improve customer satisfaction, reduce risk, improve processes, and reduce waste using the quality improvement tools of process control & monitoring, structured problem solving, and trend analysis with timely and effective signal resolution. Your Skills and Expertise To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications: Bachelor’s degree or higher (completed and verified prior to start) in Science /Technical Three (3) years of Medical Device, Pharmaceutical, or Combination Product experience in a Quality or Regulatory function in a private, public, government. English and Japanese verbal and written communication skills with the ability to provide diligent, concise, and fact-based communication to cross-functional peers, and direct report team and customers. Additional qualifications that could help you succeed even further in this role include: Skills including, but not limited to, Medical Device Manufacturing, Nonconforming Material Control, Customer Interaction and Support, Continuous Process Improvement, Field Actions & Recalls, and Organizational are preferred. Demonstrated experience in ensuring compliance of Quality Systems and/or Quality Assurance Medical Device, Pharmaceutical, or Combination Product experience in a private, public are preferred. Demonstrated successful organizational influence in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and process capability and efficiency enhancement Leadership, decision-making, problem-solving, continuous improvement, and management skills with the demonstrated ability to create momentum and deliver results in a timely manner For current employees, internal transfer restrictions may not apply. For more details, contact your local recruiter/HR team. Work location: Kanagawa, Japan 所在地:相模原 Work Your Way Eligible (Employee choice to work remote, on site, or hybrid) Hybrid Eligible Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). |
応募資格 |
【必須(MUST)】 Three (3) years of Medical Device, Pharmaceutical, or Combination Product experience in a Quality or Regulatory functionISO 13485, ISO 14971, PMDA 【歓迎(WANT)】 English verbal and written communication skills |
受動喫煙対策 | 喫煙室設置 |
更新日 | 2024/03/04 |
求人番号 | 3336813 |
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転職・求人情報の詳細をご覧になる場合は会員登録(無料)が必要です