Quality Engineer

Akkodis is seeking a Quality Engineer for a contract job in Milpitas, California, United States, Onsite

Pay Range: $45/hr - $46/hr on W2

(The rate may be negotiable based on experience, education, geographic location, and other factors.)

Job Title : Quality Engineer

Location: Milpitas, California United States

Duration: 12 Month+(Possible to Extend)

Exp Required : 5+ Years

Job Summary

We are seeking a detail-oriented Quality Engineer to support quality assurance and compliance activities for medical device products. The ideal candidate will ensure that products and processes meet regulatory requirements, quality standards, and customer expectations throughout the product lifecycle. This role involves working closely with cross-functional teams to drive continuous improvement, manage quality systems, and support regulatory compliance.

Key Responsibilities

• Develop, implement, and maintain quality systems in compliance with FDA, ISO 13485, and other applicable regulatory requirements.
• Support product development and manufacturing teams by applying quality engineering principles and risk management methodologies.
• Conduct root cause investigations and implement corrective and preventive actions (CAPA) for quality issues.
• Lead and participate in nonconformance investigations, complaint handling, and quality audits.
• Perform risk assessments, including FMEA, hazard analysis, and process validation activities.
• Review and approve engineering changes, manufacturing procedures, and quality documentation.
• Analyze quality metrics and trends to identify opportunities for process improvements.
• Support supplier quality activities, including supplier qualification, audits, and performance monitoring.
• Participate in internal, external, customer, and regulatory audits.
• Ensure compliance with Good Manufacturing Practices (GMP), FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and other applicable standards.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Operations teams to maintain product quality and regulatory compliance.
• Assist in validation activities, including IQ, OQ, PQ, and process validation protocols.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Biomedical Engineering, Mechanical Engineering, or a related technical field.
• 3+ years of quality engineering experience within the medical device, pharmaceutical, or highly regulated manufacturing industry.
• Strong knowledge of FDA regulations, ISO 13485, GMP, CAPA, and risk management principles.
• Experience with root cause analysis tools such as 5 Whys, Fishbone Diagrams, and Failure Mode and Effects Analysis (FMEA).
• Experience supporting audits and regulatory inspections.
• Proficiency with quality tools, statistical analysis, and process improvement methodologies.
• Strong technical writing, problem-solving, and communication skills.

Preferred Qualifications

• Knowledge of Medical Device Reporting (MDR) and complaint handling processes.
• Experience working with Class I, II, or III medical devices.
• Familiarity with Lean Manufacturing and Six Sigma methodologies.

Skills

• Quality Management Systems (QMS)
• CAPA Management
• Root Cause Analysis
• Risk Management (FMEA)
• Process Validation (IQ/OQ/PQ)
• ISO 13485
• FDA 21 CFR Part 820
• Supplier Quality Management
• Internal and External Auditing
• Statistical Analysis & SPC
• Continuous Improvement

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance