Quality Engineer (Complaint Investigation)

OVERVIEW:

About the job:

***NO Visa Sponsorship/ No H1Bs/ No C2Cs***

Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Quality Engineer (Complaint Investigation)

** JOB #: 2809

** JOB TITLE: Quality Engineer (Complaint Investigation)

** JOB LOCATION: Onsite at 17200 Laguna Canyon Road Irvine CA 92618

** JOB DURATION: Duration: 12-month contract (possible extension)

Pay Rate: $45.00/hr. – $47.00/hr.

POSITION SUMMARY

The Quality Engineer supports product and service quality by conducting complaint investigations, engineering evaluations, and resolving equipment and process-related production issues. This role works cross-functionally to ensure compliance with quality standards and regulatory requirements while supporting validation, data analysis, and continuous improvement efforts.

KEY RESPONSIBILITIES:

Quality & Complaint Investigations

• Conduct complaint investigations and perform engineering evaluations for complaint closure.
• Assist in root cause analysis and failure investigations.
• Perform failure mode and root cause assessments, particularly for electronic devices.

Process & Product Support

• Support resolution of equipment, process, material, and method-related issues.
• Participate in validation activities, including process and equipment validation.
• Apply statistical analysis and metrics to evaluate system and process performance.

Documentation & Reporting

• Write test protocols, execute testing, collect data, and generate reports.
• Ensure documentation aligns with validation plans and intended product use.

Regulatory & Compliance

• Apply knowledge of FDA, ISO, and cGMP requirements in daily work.
• Ensure compliance with quality engineering policies, procedures, and best practices.

Cross-Functional Collaboration

• Work closely with cross-functional teams to resolve quality issues.
• Communicate findings and updates effectively through written and verbal channels.

JOB REQUIREMENTS

• Education: Basic understanding of quality engineering principles and practices
• Knowledge of FDA, ISO, and cGMP regulatory requirements
• Experience with complaint investigations and engineering evaluations
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work under supervision while developing technical expertise

Recruiter Contact Info

Lalit Malgotra

Email: lalit.malgotra@ameritconsulting.com

www.ameritconsulting.com

I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.