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M
modis
Sr. Product Quality Engineer
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What they do
A Product Quality Engineer evaluates and tests products and manufacturing systems, to ensure that products are produced that meet quality and performance standards as well as safety and regulatory requirements. Develops product quality standards and monitors production and product testing.
$106,540 / year median in California
+6% projected growth
Job Description
Akkodis is seeking an Sr. Product Quality Engineer for a Contract with a client in Alameda, CA. The ideal candidate with expertise leading complaint trend analysis, quality investigations, and risk assessment activities to identify emerging product and process issues within regulated manufacturing environments.
Mathur@ akkodisgroup.com.
Rate Range:
$60/hour to $70/hour; The rate may be negotiable based on experience, education, geographic location, and other factors. Sr. Product Quality Engineer Job Responsibilities include: Lead complaint trending, quality data analysis, and post-market surveillance activities to identify emerging product, process, and compliance risks. Investigate complaints, CAPAs, non-conformances, and manufacturing quality issues using statistical analysis and root cause investigation methodologies. Develop and maintain dashboards, reports, and visualizations using Excel, Power BI, SQL, JMP, and Python to support data-driven quality decisions. Collaborate with Quality, Manufacturing, Operations, and R&D teams to evaluate quality trends, assess risks, and implement corrective and preventive actions. Present investigation findings, risk assessments, and improvement recommendations to leadership, quality review boards, and cross-functional stakeholders. Support regulatory compliance, audits, inspections, and continuous improvement initiatives while mentoring junior engineers and driving quality excellence across the organization.Required Qualifications:
Bachelor's degree in engineering, Biomedical Engineering, Quality Engineering, Life Sciences, or a related technical field. 4-8 years of experience in Quality Engineering, Medical Devices, Pharmaceuticals, Biotechnology, or other FDA/ISO-regulated environments. Strong experience with complaint handling, CAPA investigations, root cause analysis, risk management, and post-market surveillance trending activities. Proficiency in quality data analytics and reporting tools including Excel, Power BI, SQL, JMP, and Python, with the ability to identify trends, assess risks, and present data-driven recommendations to stakeholders. If you are interested in this role, then please clickAPPLY NOW.
For other opportunities available at Akkodis, or any questions, feel free to contact me at Udbhav.Mathur@ akkodisgroup.com.