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Director, Manufacturing Quality, GIS (Japan Based)

Olympus Corporation of the Americas · Remote · Quality & Regulatory Affairs (QA/RA)

Compensation

$135k – $189k /yr

Employment type

Full-time

Work setting

Remote

Location

Remote

Schedule

Day shift

Posted

Travel

Required

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Job overview

The Director, Manufacturing Quality, GIS is a remote-based role requiring relocation to Japan for a 2-3 year assignment, with a salary range of $134,666.00 - $188,532.00 per year. This position supports the Quality & Regulatory Affairs team at Olympus, a global medical technology company. This role exists to provide strategic leadership at the Aizu Manufacturing Location in Japan. It contributes to the company by ensuring compliance with regulatory requirements and directing the execution of the Quality Management System.

What you'll do

  • Lead site Quality organization
  • ensure compliance with FDA QSR, ISO 13485, and MDR
  • serve as Management Representative
  • oversee CAPA system
  • manage complaint handling
  • ensure control of nonconforming product
  • lead internal and regulatory audits
  • monitor performance metrics.

What we're looking for

Education
Bachelor's degree or equivalent.
Experience
Minimum of 10 years of Quality experience, preferably in the medical device industry.
Skills & competencies
full-time
day shift
remote
japan assignment
olympus
director
quality
manufacturing
$135k-$189k
travel required
no on-call
no weekends
Work arrangement
  • Weekend coverage required

About the employer

Olympus Corporation of the Americas is hiring for this role. Industry: Surgical Appliance and Supplies Manufacturing. Sector: 33.

Additional details

Industry sector
33
Industry
Surgical Appliance and Supplies Manufacturing
Occupation code
11-3051.01
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