Manufacture quality engineer

Northridge, CA, US • Posted 1 day ago • Updated 13 hours ago
Contract W2
Contract Corp To Corp
12 Months
On-site
Depends on Experience
Company Branding Image
Fitment

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Job Details

Skills

  • medical device manufacturing quality
  • GMP
  • Regulatory and quality systems
  • QMS

Summary

Job Summary:

Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances. The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams.

Key Responsibilities:

  • Monitor manufacturing processes to ensure product quality and compliance with defined standards.
  • Manage non-conformances (NCR), deviations, and CAPA activities.
  • Perform root cause analysis (RCA) and implement corrective and preventive actions.
  • Support internal and external audits (FDA, ISO).
  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
  • Maintain and update Quality Management System (QMS) documentation including SOPs, DHF, DMR, and DHR.
  • Collaborate with manufacturing, engineering, and supplier teams to resolve quality issues.
  • Drive continuous improvement initiatives using Lean Six Sigma methodologies.
  • Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
  • Ensure proper documentation and traceability of manufacturing and quality records.

Skill Requirements:

  • Manufacturing Quality
  • GMP
  • ISO 13485
  • FDA 21 CFR 820
  • CAPA
  • NCR
  • Root Cause Analysis (RCA)
  • Risk Management (FMEA)
  • Statistical Process Control (SPC)
  • Audit Compliance
  • Quality Management System (QMS)
  • Continuous Improvement

Other Requirements:

  • Bachelor s degree in engineering or related field.
  • Experience in medical device manufacturing preferred.
  • Strong understanding of regulatory and quality systems.
  • Good communication and cross-functional collaboration skills.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91131463
  • Position Id: 9021402
  • Posted 1 day ago

Company Info

About Saim Technologies

Saim Technologies provides a variety of services related to Information Technology and out sourcing and has been recognized as a one of the emerging leader in software solutions. We provide custom software development, Staffing, Training and engineering services. We offer Enterprise level web based applications, web services, technical resources, Enterprise level database, software hosting, technical support services, routine programming, and more.

Our IT services focus on providing you with increased business performance by leveraging our technological expertise, business knowledge, process quality, and people. Our dedicated Centers of Excellence and practices around each of our service offerings enable us to continuously improve processes, retain project learning, and expand knowledge repositories to deliver consistent value.

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Contact the job poster
RV

Radha Venkatraman

Recruiter @ Saim Technologies
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