Med Device Quality Engineer

Company : inSync Staffing

Country: United States

Location : San Jose, California

Post: Thu, 23 Mar 2023 06:31:16 GMT

Expires: Thu, 20 Apr 2023 23:59:59 GMT

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—————————— Job Description ——————————

If you are not interested but refer someone who gets hired. We will give you a $150.00 Amazon card referral/finders incentive after 30 days of your referral being on the job.

Quality Engineer 2

Location San Jose, CA

Pay Rate: $38.00 – $42.00

Duration: 6 Months (Temp to Hire)

Day Shift

Job Description

EDUCATION AND EXPERIENCE REQUIREMENTS:

BA/BS in engineering or science degree.

3-5 years experience in the medical device industry, knowledgeable of Quality System Regulation (QSR) and ISO 13485.

Understanding of troubleshooting principles, cause analysis tools, and statistical concepts, including hypothesis testing and sampling plans.

Ability to identify, analyze and solve problems with minimal direction.

Basic working knowledge of Microsoft Office applications including Word, Visio, Project, and PowerPoint or similar.

Excellent verbal and written communication skills.

Provide leadership and guidance to the company to ensure the quality system requirements are effectively established and maintained per 21 CFR Part 820 and ISO 13485 and other regulations as applicable.

MAJOR DUTIES AND RESPONSIBILITIES :

Perform, coordinate, assist, and provide guidance on failure analysis, complaint investigation, material non-conformances, and CAPA.

Perform in-process and incoming quality inspections.

Provide quality engineering support on equipment qualification and product validation testing.

Support sterilization validation and biocompatibility testing activities.

Assist in company quality system training program.

Assist in evaluating and developing new suppliers. Lead supplier quality system audits and monitoring support, as necessary.

Issue, track, verify and close supplier CAPA.

Interface with customers and outside testing laboratories.

Create, implement, and maintain quality systems to current standards and customer requirements.

Support internal and external audits as necessary.