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Job Details

Sr. QA Engineer

Company name
Mizuho OSI

Experience
1 yrs required

Location
Union City, CA

Apply for this job






Profile

SCOPE:

The Sr. Quality Assurance Engineer is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. The position manages quality assurance programs and processes to ensure the quality of product conforms to the established procedures and applicable regulatory requirements. The position utilizes technical expertise on the FDA’s QSR, ISO 13485, ISO 14971, MDD for Class I and Class II medical devices for capital equipment and their accessories.

The Sr. Quality Assurance Engineer position supports Mizuho OSI in achieving established goals and objectives and follows the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI.

 

EDUCATION AND EXPERIENCE: Bachelor’s degree in Science, or related field and 5 to 7 years of related experience in mechanical or electro machinal medical device manufacturing.

QUALIFICATIONS:

  1. Experience with mechanical and electro-mechanical medical device manufacturing.
  2. Previous experience with managing quality systems: CAPA, Complaints processing, NCR, Deviations.
  3. Thorough knowledge on ISO standards, FDA’s QSR, MDD and other regulations as applicable to Mizuho OSI’s product.
  4. ASQ Certification for CQE, CQA. Auditor certification for ISO 13485 is desirable.
  5. Demonstrated knowledge of engineering applications, CAD and Solid Modeling software
  6. General understanding of Geometric Dimensioning and Tolerance (GD&T) skills
  7. Familiarity with “Lean” manufacturing principles is preferred
  8. Ability to work independently and collaboratively with small and cross functional teams.
  9. Excellent computer skills including operating Windows based personal computers, various office equipment and machines, and telephone system. Ability to efficiently and effectively use Microsoft products such as Outlook, Word, Excel, Project, Visio and PowerPoint to analyze data, produce trend charts and presentation.
  10. Ability to perform basic statistical analysis, calculating C&R, create and reconcile reports, demonstrate strong analytical skills, and attention to detail.

To apply online, please visit us by clicking "Apply Now".

 

 

Company info

Mizuho OSI

Company Profile
Mizuho OSI is a U.S. based company founded over 40 years ago and the leader in the specialty surgical table and patient positioning markets. We are part of an international company, Mizuho Corporation based in Japan, who has more than 99 years of proven innovation in the medical device area, making us a truly global organization.   We share a responsibility and commitment with our healthcare partners to provide cost-effective and innovative solutions that effectively meet the needs of all the surgeons who use our products.   Mizuho OSI continues to collaborate with world class surgical and patient care thought leaders to ensure our products produce the most favorable patient outcomes possible. Our extensive innovative product portfolio and extraordinary services position the company to attract and maintain long relationships with our customers.

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