Quality Engineer III​/Sr. Quality Engineer

Contract

JOHNSON & JOHNSON / CALIBRA

Title:

Sr. Quality Engineer for Swing Shift
Supervisor: QA Manager

Location:

Redwood City, CA
Purpose of Position:
Supports production of clinical devices and process development. Maintains compliance to Medical Device Directives (MDD), ISO 13485, and Quality System Regulations for Design Controls. Creates protocols and reports for device manufacturing and testing where needed. Performs specific data analysis and trending as required. Provides technical support to Manufacturing and R&D.

Essential Functions:

• Assists in assuring that Good Manufacturing Practice requirements are met, including Design Control.
• Performs review of production LHR and signoff as required.
• Reviews currently manufacturing process documentation and records.
• Works with Quality and Operations to maintain quality requirements in the support of clinical builds.
• Develops and implements specific testing for existing and new products including supporting process validations.
• Provides support to manufacturing inspection process development.
• Researches and provides guidance to the design team regarding standards and regulations applicable to the development project.
• Performs other duties in quality assurance as directed.
• Works in accordance with quality system procedures.

Minimum Requirements:

• BS/BA in an Engineering discipline preferred, equivalent combination of education and work experience acceptable.
• 5 years of experience in Quality Engineering in the medical device industry.
• ASQ Certified Quality Engineer certification preferred.

Essential Knowledge, Skills, and Abilities:

• Must have strong oral and written communication skills.
• Strong knowledge in the use of manufacturing processes used in the medical device industry.
• Strong knowledge of statistical data analysis.
• Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO
  14971.

Job duties are typically performed in an office environment. Overall duties require the ability to stand or sit for lengthy periods of time in a lab. Required duties include utilizing standard office equipment such as a computer, photocopier, and telephone, and reading and writing.

Travel:
Some out of town travel may be required for supplier interactions (anticipated to be 10% of time)

Personal Protective Equipment:
Latex/rubber/heat resistant gloves, UV eye protection, safety glasses, goggles, respirators, splash aprons, cleanroom gowning wear (smocks, head covers, beard covers, shoes covers)

Johnson & Johnson is an equal employment opportunity company.