Quality Engineer III / Sr. Quality Engineer

LanceSoft Inc; Redwood City (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading medical device company is seeking a Sr. Quality Engineer for Swing Shift in Redwood City, CA. The candidate will support the production of clinical devices while ensuring compliance with regulations. Responsibilities include developing testing processes, performing data analysis, and providing technical support to manufacturing. Candidates should have a degree in Engineering and at least 5 years of experience in the medical device industry. Preferred certification as an ASQ Certified Quality Engineer and strong communication skills are essential.

Qualifications

• Minimum of 5 years of experience in Quality Engineering in the medical device industry.
• ASQ Certified Quality Engineer certification preferred.

Responsibilities

• Support production of clinical devices and process development.
• Maintain compliance with Medical Device Directives.
• Create protocols and reports as needed.
• Perform data analysis and trending.
• Provide technical support to Manufacturing and R&D.

Skills

Strong oral and written communication skills

Knowledge of manufacturing processes in the medical device industry

Statistical data analysis

Education

BS/BA in an Engineering discipline

Job description

• Contract

Company Description

JOHNSON & JOHNSON / CALIBRA

Job Description

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. Create protocols and reports for a device manufacturing and testing where needed. Perform specific data analysis and trending as required. Provide 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.
• Perform other duties in quality assurance as directed.
• Works in accordance with quality system procedures.

Minimum Education: BS/BA in an Engineering discipline preferred, equivalent combination of education and work experience acceptable.

Minimum Experience: 5 years of experience in Quality Engineering in the medical device industry.

Licenses, Certifications, and Registrations: ASQ Certified Quality Engineer certification preferred.

Other 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/ISO14971.

Working Environment

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).