quality engineer

quality engineer.

• irvine , california

• posted 3 days ago

job details

summary

• $33.70 - $36 per hour

• contract

• bachelor degree

• category computer and mathematical occupations

• reference1072184

job details

job summary

A Quality Engineer is needed for a Swiss-American pharmaceutical and medical device company specializing in eye care products in the Irvine, CA area. This position is responsible for ensuring the quality and compliance of medical devices through process control, root cause analysis, risk management, and collaboration with cross-functional teams to meet regulatory standards and company objectives.

location: Irvine, California

job type: Contract

salary: $33.70 - 36.00 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities

• Develops and executes quality and control plans to ensure manufacturing continuity and product conformance

• Leads investigations into production and customer quality issues, implementing corrective and preventative actions

• Monitors medical device performance using statistical and risk-based approaches to assess quality, compliance, customer, and business risks

• Performs hands-on troubleshooting of customer-returned devices and manufacturing nonconformities, completing related technical documentation

• Communicates complex technical issues and solutions effectively to various audiences within the organization

• Utilizes project management, data analysis, root cause analysis, communication, and risk assessment skills

• Ensures compliance with Quality System policies and external standards, including FDA, ISO 13485, and other medical device regulations

Minimum Qualifications

• Bachelor's degree in Engineering

• 1-2 years of experience in a regulated industry (FDA environment preferred)

qualifications

• Experience level: Experienced

• Education: Bachelors

skills

• Quality

• Compliance

• Manufacturing

• Medical DeviceEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group ~~~ Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ~~~ offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for ~~~ will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.