Find & Apply For Quality Inspector / Technician Jobs in Temecula, California

Quality Engineer Golden West Biologicals, Inc Temecula, CA Job Details Full-time $75,000 - $95,000 a year 17 hours ago Benefits Health savings account Health insurance 401(k) Flexible spending account Paid time off 401(k) matching Retirement plan Qualifications Microsoft Excel Defect resolution root cause analysis ISO standards Preventive action implementation Production deviation management Laboratory experience Quality control preventive actions Corrective and preventive actions (CAPA) Manufacturing standard operating procedures Manufacturing facility experience Quality assurance standard operating procedures Compliance documentation Incident Investigation Biomedical regulatory compliance Productivity software Quality audits Training & development Standard operating procedures (SOPs) Supplier quality assurance (SQA) Standard operating procedures drafting Failure analysis

Full Job Description Quality Engineer Golden West Biologicals Location:

Temecula, CA Schedule:

Full-time /

On-site Compensation:

$75,000 - $95,000 About Golden West The Golden West Companies provide biological materials and specialty products used in research, diagnostic development, and manufacturing. Our businesses include Golden West Diagnostics, which manufactures processed sera, specialty matrices, and other materials for assay development and manufacturing, and Golden West BioSolutions, which provides human biological specimens, including disease-state samples, to support research and product development. Our work supports customers developing diagnostic assays, standards, controls, and other laboratory products. Quality is essential to ensuring that our materials meet agreed specifications and that the documentation supporting them is accurate, complete, and traceable. About the Role Golden West Biologicals is seeking a hands-on Quality Engineer to support quality activities across the Golden West Companies. We are consolidating quality assurance into a single quality management system managed by one team, and this position will play a central role in implementing, maintaining, and improving that system. You will work closely with leadership and employees across manufacturing, operations, purchasing, and sales to develop clear procedures, investigate quality issues, implement corrective actions, and establish consistent practices across the businesses. This is an individual contributor position with no direct reports. You will personally perform the technical quality work, with a QA Administrator supporting routine document coordination, recordkeeping, logs, and tracking. We are looking for someone who enjoys working directly with processes and documentation, exercises sound judgment, and takes ownership of work from identifying an issue through verifying that the solution is effective. Key Responsibilities Support the consolidation of existing quality systems, procedures, and records into a unified QMS. Maintain and improve the shared QMS, ensuring procedures reflect actual operations and applicable requirements. Identify gaps, conflicting requirements, and duplicated processes, and work with process owners to resolve them. Write, review, and revise SOPs, work instructions, forms, and other controlled documents. Evaluate proposed document and process changes for quality impact, implementation needs, and training requirements. Lead corrective and preventive actions, including root cause investigations, action planning, implementation, and effectiveness verification. Investigate nonconforming materials and process deviations, assess product impact, and coordinate appropriate disposition and corrective action. Investigate customer complaints, coordinate responses with internal teams, and identify recurring issues requiring further action. Evaluate supplier qualifications and performance and coordinate follow-up on quality concerns. Plan and conduct internal audits, coordinate responses to findings, and support customer, certification, and other external audits. Prepare quality metrics, trends, and recommendations for management review and follow through on assigned actions. Identify training needs arising from procedure changes or quality issues, provide training, and assess its effectiveness. Perform or support reviews of Certificates of Analysis (COAs), labels, manufacturing records, and other product documentation for accuracy and conformance to established requirements. Work with operations and leadership to improve processes, prevent recurring errors, and establish clear, usable quality controls. Partner with the QA Administrator to ensure quality records are complete and required activities are completed on time. Perform other related quality duties as assigned. Qualifications At least three years of hands-on quality experience in a manufacturing or similarly controlled environment. Demonstrated experience maintaining and improving an

ISO 13485

quality management system. Practical experience with CAPAs, root cause analysis, nonconformances, complaints, document control, supplier qualification, and audits. Ability to independently write clear procedures and produce thorough, accurate investigation records. Experience with biological materials, diagnostics, medical devices, or laboratory manufacturing preferred. Experience consolidating quality systems or standardizing processes across multiple operations preferred. Proficiency in Microsoft Word and Excel. Strong written and verbal communication skills. What Success Looks Like You take ownership of assigned work and complete it without repeated follow-up. You are comfortable working directly with records, products, and processes. You communicate concerns clearly and respectfully and escalate issues when needed. You develop practical solutions and verify that they work. You balance multiple priorities while maintaining accuracy and meeting deadlines. You work effectively across departments and help employees understand and apply quality requirements.

Pay:

$75,000.00 - $95,000.00 per year

Benefits:

401(k) 401(k) matching Flexible spending account Health insurance Health savings account Paid time off Retirement plan

Work Location:

In person