Quality Systems Engineer - Medical Devices (ISO 13485)

TSK Laboratory Europe B.V.; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive salary based on experience

Health, dental, and vision insurance

401K retirement plan with company matching

Entrepreneurial team environment

Job summary

A global medical technologies firm is seeking a Quality Assurance Specialist to develop and maintain compliance procedures. The ideal candidate will have a Bachelor's degree and 3 to 5 years of experience in the medical device sector. Responsibilities include document control, change management, and complaint handling. Competitive salary and benefits, including health insurance and a 401K match, offered.

Qualifications

• 3 to 5 years’ experience in quality assurance, preferably in the medical device sector.
• Experience in the application of statistics and data analysis to quality systems.

Responsibilities

• Document Control: maintain quality management system documents.
• Change Management: coordinate and track changes to documentation.
• Nonconformances and CAPAs: investigate, analyze and report nonconformances.
• Complaint handling: facilitate investigation and closure of complaint cases.
• Perform data entry and statistical analysis for QMS modules.

Skills

Strong knowledge of ISO standards

Strong English communication skills

Knowledgeable in problem-solving techniques

Ability to work collaboratively

Written and verbal communication skills in Japanese

Education

Bachelor’s degree in engineering, science or related field

Certified engineer preferred

Job description

A global medical technologies firm is seeking a Quality Assurance Specialist to develop and maintain compliance procedures. The ideal candidate will have a Bachelor's degree and 3 to 5 years of experience in the medical device sector. Responsibilities include document control, change management, and complaint handling. Competitive salary and benefits, including health insurance and a 401K match, offered.