Slingshot Connections
Fremont, CA
Order: 1706382
Order Type : Temp
Job Title: Quality Engineer
Location: Fremont, CA
Pay: $90k-$100k
About the job:
The Quality Engineer will ensure compliance with regulatory standards and support continuous improvement in manufacturing processes and products. This role collaborates with cross-functional teams to maintain quality systems, investigate non-conformances, and drive initiatives that enhance product quality and efficiency.
We're looking for someone who: • Has a bachelor's degree in Engineering, Quality Assurance, or a related field (advanced degree preferred) • Brings 5+ years of quality engineering experience in the medical device industry • Understands ISO 9001, ISO 13485, and CFR 820 standards and requirements • Excels at root cause analysis, CAPA management, and NCR resolution • Is detail-oriented, analytical, and committed to compliance and quality excellence • Communicates effectively and works collaboratively with cross-functional teams • (Preferred) Has experience with cleanroom operations and contamination control practices • (Preferred) Has experience in supplier quality management, including audits and SCARs • (Preferred) Holds CQE or CQA certification
What you'll do: • Investigate and resolve non-conformances, deviations, and customer complaints using CAPA
methodologies • Generate and manage CAPAs, NCRs, and corrective actions to ensure timely resolution • Update and revise SOPs, quality procedures, and work instructions for compliance and efficiency • Perform inspections of finished goods, raw materials, and components to verify compliance with
specifications • Oversee equipment calibration and ensure accuracy of test and measurement systems • Provide quality-related guidance and support to manufacturing teams • Conduct supplier audits and assessments to evaluate performance and compliance • Participate in cleanroom activities and ensure compliance with ISO 14644 standards • Analyze data, identify trends, and implement best practices to drive continuous improvement
Why you'll love working here: • Weekly pay • Paid sick leave • Health, vision, dental, pet insurance, and more
Order: 1706382
Order Type : Temp
Job Title: Quality Engineer
Location: Fremont, CA
Pay: $90k-$100k
About the job:
The Quality Engineer will ensure compliance with regulatory standards and support continuous improvement in manufacturing processes and products. This role collaborates with cross-functional teams to maintain quality systems, investigate non-conformances, and drive initiatives that enhance product quality and efficiency.
We're looking for someone who: • Has a bachelor's degree in Engineering, Quality Assurance, or a related field (advanced degree preferred) • Brings 5+ years of quality engineering experience in the medical device industry • Understands ISO 9001, ISO 13485, and CFR 820 standards and requirements • Excels at root cause analysis, CAPA management, and NCR resolution • Is detail-oriented, analytical, and committed to compliance and quality excellence • Communicates effectively and works collaboratively with cross-functional teams • (Preferred) Has experience with cleanroom operations and contamination control practices • (Preferred) Has experience in supplier quality management, including audits and SCARs • (Preferred) Holds CQE or CQA certification
What you'll do: • Investigate and resolve non-conformances, deviations, and customer complaints using CAPA
methodologies • Generate and manage CAPAs, NCRs, and corrective actions to ensure timely resolution • Update and revise SOPs, quality procedures, and work instructions for compliance and efficiency • Perform inspections of finished goods, raw materials, and components to verify compliance with
specifications • Oversee equipment calibration and ensure accuracy of test and measurement systems • Provide quality-related guidance and support to manufacturing teams • Conduct supplier audits and assessments to evaluate performance and compliance • Participate in cleanroom activities and ensure compliance with ISO 14644 standards • Analyze data, identify trends, and implement best practices to drive continuous improvement
Why you'll love working here: • Weekly pay • Paid sick leave • Health, vision, dental, pet insurance, and more