Manufacturing Quality Engineer II

Job Title:

Manufacturing Quality Engineer II

Pay Rate: $45 to $49.97/HR

Duration:
12 months

Our Client is a Global medical device Manufacturer.

We are looking for a Manufacturing Quality Engineer II to support manufacturing quality operations. This individual will lead product and process investigations
, perform root cause analysis
, support validation activities, and ensure compliance with quality and regulatory requirements. The ideal candidate has experience working in an FDA-regulated or medical device manufacturing environment and is skilled in CAPA
, material disposition
, and quality system processes.

• Conduct investigations into product, process, and manufacturing quality issues
  .
• Perform root cause analysis and implement effective corrective and preventive actions (CAPA).
• Own and manage material disposition decisions and material quarantine processes.
• Review and assess supplier changes to ensure compliance with quality requirements.
• Support equipment and process validation activities, including IQ/OQ/PQ
  .
• Execute and document test method validation (TMV) activities.
• Support CAPA investigations
  , implementation, and effectiveness verification.
• Collaborate with Manufacturing, Supplier Quality, Engineering, and Operations teams to resolve quality issues.
• Ensure compliance with FDA regulations, internal quality systems, and applicable industry standards.
• Utilize Microsoft Office and other enterprise systems to document investigations, analyze data, and generate reports.
• Drive continuous improvement initiatives to enhance product quality and manufacturing performance.

Requirements :

• 2–4 years of Manufacturing Quality Engineering experience.
• Experience conducting investigations
  , root cause analysis
  , and corrective actions
  .
• Hands‑on experience with CAPA processes.
• Experience with material disposition and quarantine management.
• Experience supporting IQ/OQ/PQ validation activities.
• Experience performing Test Method Validation (TMV).
• Strong understanding of quality systems and regulatory compliance.
• Advanced proficiency in Microsoft Office (Excel, Word, PowerPoint).
• Strong technical aptitude with the ability to quickly learn and navigate multiple software applications.
• Excellent analytical, problem-solving, and communication skills

Nice to Have

Skills:

• Experience in the Medical Device industry.
• Experience working in an FDA-regulated manufacturing environment
  .
• Candidates from other highly regulated industries such as:
• Food Manufacturing
• Automotive
• Aerospace
• Knowledge of supplier quality processes and supplier change management.
• Experience with nonconformance investigations and quality improvement initiatives.