Quality Engineer- Life Sciences

At FUJIFILM Biosciences we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media discovery research reagents recombinant growth factors and proteins fine chemicals and critical assay materials we partner with the brightest minds in biotech and pharma to tackle the worlds biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines therapies and advancements in regenerative medicine. Our culture fosters curiosity collaboration and innovation and we pride ourselves on delivering unparalleled quality and service to our partners. If youre ready to make an impact your future belongs with us at FUJIFILM Biosciences.

Our headquarters in Santa Ana California is surrounded by world-class schools lush parks and scenic beaches like Laguna and Huntington making it an ideal place to live work and explore. With additional campuses across the US Europe China and Japan we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

We are hiring a Quality Engineer. The Quality Engineer will be responsible for ensuring quality system compliance by driving the resolution of quality events.

Responsibilities:

• Lead quality event investigations (e.g. NONC and DEV) and ensure timely resolution.
• Lead cross-functional meetings and present investigation outcomes quality risks and recommendations to management.
• Perform investigations (6M 5WHY RCA) risk assessments and verifications of effectiveness.
• Compile and analyze data utilizing statistical tools and techniques for quality events and process monitoring.
• Generate and revise documents (e.g. SOPs).
• Support audits corrective and preventative action (CAPA) investigations and process improvement initiatives.
• Collaborate effectively with cross-functional teams to achieve KPIs and objectives.
• May be required to perform other duties as needed.

Required Skills/Education:

• A minimum of a Bachelors degree or equivalent in an Engineering discipline.
• A minimum of five (5) years of relevant work experience.
• Knowledge of ISO standards and FDA guidelines/rules/regulations for medical device / pharmaceuticals.
• Experience with deviation and nonconformance investigations root cause analysis CAPA SCAR and change control.
• Ability to speak read and write English proficiently.
• Proficient oral and written communication skills.

Salary and Benefits:

• For California the base salary range for this position is $106185.25- $125000. Compensation for the successful candidate will depend on various factors (e.g. qualifications education prior experience location etc.).
• Medical Dental Vision
• Life Insurance
• 401k
• Paid Time Off

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Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().