Senior Quality Engineer

Senior Quality Engineer Balance Staffing - 3.5 Fremont, CA Job Details Contract $60 - $65 an hour 1 day ago Benefits Health insurance Dental insurance Paid time off Vision insurance Life insurance Qualifications Quality control corrective actions Teamwork ISO standards Regulatory compliance Compliance audits & assessments Corrective and preventive actions (CAPA) Project management Quality inspection Data interpretation Manufacturing Root cause analysis Cross-functional collaboration Manufacturing company experience Cross-functional communication Training delivery Full Job Description Temp-hire. Monday - Friday, 8am - 4pm. Job Overview We are seeking a highly skilled and experienced Senior Quality Engineer to join our dynamic manufacturing team. This pivotal role involves leading quality assurance initiatives, ensuring compliance with industry standards, and fostering continuous improvement across production processes. The ideal candidate will possess a comprehensive understanding of quality systems, regulatory requirements, and manufacturing practices, contributing significantly to the delivery of safe, reliable, and high-quality products. This position offers an opportunity to influence quality culture and drive excellence throughout the organization. Responsibilities Develop, implement, and maintain quality management systems aligned with ISO standards and US and International medical device regulations. Lead internal and external quality audits to verify compliance with regulatory requirements and company policies. Oversee quality control processes including inspections, testing, and validation activities to ensure product integrity. Collaborate with cross-functional teams to identify root causes of quality issues and implement corrective and preventive actions. Ensure adherence to manufacturing protocols such as troubleshooting issues (defects, production issues), verification, and overseeing calibration. Analyze data from quality metrics to monitor trends, identify areas for improvement, and support strategic decision-making. Provide guidance on regulatory documentation preparation for audits and inspections. Lead initiatives for continuous improvement in quality systems, processes, and product reliability. Facilitate training sessions on quality standards, procedures, and compliance requirements for staff. Support project management efforts related to new product development or process upgrades with a focus on quality assurance. Requirements Proven experience as a Quality Engineer or similar role within a manufacturing environment. Strong understanding of quality inspection techniques, quality control methods, and quality assurance practices. Demonstrated ability to conduct comprehensive quality audits and manage non-conformance issues effectively. Expertise in developing and maintaining quality systems aligned with industry standards. Excellent analysis skills with the ability to interpret complex data sets for process improvements. Experience in project management with a focus on quality initiatives. Exceptional communication skills for effective collaboration across departments. Bachelor's degree in Engineering, Quality Management, or a related field OR a Master's degree in Engineering, Chemistry, Material Science preferred. Experience building a quality system. Medical device experience (ISO 13485). Join our team as a Senior Quality Engineer to lead our commitment to excellence by ensuring the highest standards of product safety and reliability. Your expertise will be instrumental in advancing our mission of delivering superior products while maintaining compliance with global regulatory frameworks.

Job Type:

Contract Pay:

$60.00 - $65.00 per hour

Benefits:

Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person