品質保証部 スペシャリスト・次期部門長

15時間前

JP, Kanagawa, Sagamihara Solventum
Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Quality Assurance Specialist (future leader)

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You'll Make in this Role

As a Quality Assurance Specialist and Near future candidate for Quality Assurance Leader of Japan, 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 Technical, 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, Solventum requires (at a minimum) the following qualifications:

  • Bachelor's degree or higher (completed and verified prior to start)  in Science /Technical
  • Two (2) years or more of in a Quality or Regulatory related 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.

In addition to the above requirements, the following are also required:

  • 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

Work location: Sagamihara, Kanagawa

·       Hybrid (Onsite and Remote): Eligible

Travel: May include up to 5% domestic/international

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being 

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. 

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of . Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the
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