Quality Engineer, Medical Devices QA & Improvement

Yoh; Redondo Beach (CA); On-site; USD 47,000 - 68,000; Full time

Job summary

Yoh is hiring a Quality Engineer for our client in Redondo Beach, CA. The role supports product and manufacturing quality through inspection, testing strategies, defect analysis, and continuous improvement in a regulated environment.

The position involves collaborating with Development, Product, Manufacturing, and Quality teams to ensure products meet ISO 13485 and applicable EU standards, with MDR experience a plus.

Qualifications

• Bachelor's degree in Engineering required; Master’s degree in Engineering preferred.
• Professional certifications or 10+ years of equivalent work experience may be considered.
• Previous experience working in a Quality Assurance environment required.
• Knowledge of ISO 13485 and applicable EU standards.
• MDR experience is a plus.
• Knowledge of Quality Assurance and testing tools.
• Knowledge of SQL and scripting.
• Strong proficiency with Microsoft Office applications.
• Excellent analytical and problem-solving skills.
• Strong attention to detail with the ability to identify issues and develop effective solutions.

Responsibilities

• Review and understand product functional and design specifications.
• Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment.
• Conduct Quality Assurance testing to ensure products meet established requirements.
• Perform statistical analysis to evaluate products or materials that do not meet required standards and specifications.
• Conduct defect analysis utilizing statistical quality and process analytical methods.
• Prepare and maintain Quality reports and support documentation control systems.
• Review returned materials and verify customer complaints, developing action plans to address identified discrepancies.
• Communicate with customers regarding Quality issues and resolutions as required.
• Partner with operators and technicians to identify and resolve day-to-day Quality Assurance issues.
• Maintain knowledge of evolving Quality Assurance codes, regulations, and industry standards.
• Document test cases and interpret technical and business objectives.
• Work closely with Development and Product teams to support Quality initiatives.
• Identify software bugs and support appropriate testing and resolution activities.
• Recommend changes and improvements to enhance overall product quality.
• Ensure products comply with company and applicable industry Quality standards.
• Develop and implement systems that promote conformity and accuracy throughout the production process.
• Collaborate with cross-functional teams to develop solutions for identified Quality and product issues.

Skills

Quality assurance

Statistical analysis

Problem solving

SQL

Scripting

Microsoft Office

Education

Bachelor's degree in Engineering

Master's degree in Engineering (preferred)

Tools

Quality Assurance tools

MS Office

Job description

Yoh is hiring a Quality Engineer for our client. In this role, you will be responsible for supporting product and manufacturing quality through inspection and testing strategies, defect analysis, statistical analysis, documentation control, and continuous improvement initiatives. The Quality Engineer will work closely with Development, Product, Manufacturing, and Quality teams to ensure products and processes meet company, customer, and industry quality standards. This position requires strong analytical and problem-solving skills with the ability to identify quality issues, develop effective solutions, and drive improvements in a regulated environment.

Industry: Medical Device
Location:Redondo Beach, CA
Compensation: $99k-104k/yr


Job Functions

• Review and thoroughly understand product functional and design specifications.
• Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment.
• Conduct Quality Assurance testing to ensure products meet established requirements.
• Perform statistical analysis to evaluate products or materials that do not meet required standards and specifications.
• Conduct defect analysis utilizing statistical quality and process analytical methods.
• Prepare and maintain Quality reports and support documentation control systems.
• Review returned materials and verify customer complaints, developing action plans to address identified discrepancies.
• Communicate with customers regarding Quality issues and resolutions as required.
• Partner with operators and technicians to identify and resolve day-to-day Quality Assurance issues.
• Prioritize and manage multiple projects while working within design specifications and budget requirements.
• Maintain knowledge of evolving Quality Assurance codes, regulations, and industry standards.
• Document test cases and interpret technical and business objectives.
• Work closely with Development and Product teams to support Quality initiatives.
• Identify software bugs and support appropriate testing and resolution activities.
• Recommend changes and improvements to enhance overall product quality.
• Ensure products comply with company and applicable industry Quality standards.
• Develop and implement systems that promote conformity and accuracy throughout the production process.
• Collaborate with cross-functional teams to develop solutions for identified Quality and product issues.
• Perform additional duties as assigned by management.

Education, Licensure and/or Experience

• Bachelor's degree in Engineering required; Master's degree in Engineering preferred.
• Professional certifications or 10+ years of equivalent work experience may be considered.
• Previous experience working in a Quality Assurance environment required.
• Knowledge of ISO 13485 and applicable EU standards.
• MDR experience is a plus.
• Knowledge of Quality Assurance and testing tools.
• Knowledge of SQL and scripting.
• Strong proficiency with Microsoft Office applications.
• Excellent analytical and problem-solving skills.
• Strong attention to detail with the ability to identify issues and develop effective solutions.
• Ability to work independently as well as collaboratively within a team environment.
• Strong written and verbal communication skills.

Physical Job Requirements

• Full-time, onsite work environment.
• Regular use of a computer, keyboard, mouse, and other standard office and technical equipment.
• Ability to work within manufacturing, Quality, and product development environments as required.
• Must be able to review detailed technical documentation, specifications, test results, and Quality records for extended periods.

Estimated Min Rate: $48.00
Estimated Max Rate: $50.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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