Senior Change Analyst (Onsite)

Working Location: CALIFORNIA, SAN JOSE 

Workplace Flexibility: Onsite

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

This position is responsible for processing change controls, coordinating CAPAs, and supporting the continued development and maintenance of Quality Assurance systems in order to ensure compliance with the requirements of 21 CFR Part 82 Quality System Regulation (QSR), ISO 13485, 21 CFR Part 11, and other quality standards. This function under general supervision works with all OSTA departments to establish and maintain robust processes systems and procedures designed to support all aspects of the OSTA Quality Management System and general continuous improvement activities.

Job Duties

• Provide GDP, electronic, and hardcopy document control guidance.
• Assist with routine and periodic internal and external audits to ensure QSR / ISO compliance is maintained at all levels of the organization.
• Review incoming audit responses to ensure they are consistent with policy.
• Support all departments on the successful execution of the internal audit schedule and policy.
• Provide quality system support during external audits and inspections.
• Support Document and Change Control processes and systems including the ongoing maintenance and improvement of databases reports and ancillary systems.
• Support CAPA and Audit processes and systems including the ongoing maintenance and improvement of databases reports and ancillary systems.
• Act as a CAPA mentor for CAPA Owners.
• Maintain and improve Quality Management System processes procedures and systems to ensure continued compliance with documented requirements and standards.
• Support continuous improvement projects related to the development maintenance and improvement of Olympus quality management systems.
• Support quality system data collection and provide regular reports to management on quality system topics such as Audit status, CAPAs, and Change Control.
• Develop curriculum and provide training and support for established OSTA quality systems.
• Perform all other duties as required.

Job Qualifications

Required:

• Bachelor’s degree with 5 years of experience preferred. High School diploma with minimum of 8 years of experience required.
• Minimum of 5-7 years experience working with quality systems preferably in a medical device company.
• Must possess excellent organizational skills with the ability to prioritize workload.
• Must possess strong computer skills including experience working with web sites and databases.
• Must have Quality System auditing experience.
• Must possess good written and verbal communication skills.
• Must be flexible self-motivated analytical detail-oriented and practical. 
• Familiarity with basic database and web site management.
• Role is onsite in San Jose, California
• Workweek is Monday – Friday

Why join Olympus?

 

We offer a holistic employee experience supporting personal a