Quality Engineer

Client:
Major Medical Device Client

Position:
Quality Engineer

Duration: 12+ Months Contract

Pay Rate: $40.00-$48.00/ Hr on W2

This role will work within the Quality Engineering team to support manufacturing and sustaining engineering activities.

The ideal candidate will have experience in Quality Engineering, including ownership of Nonconformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and oversight of engineering changes to ensure compliance with applicable quality and regulatory requirements, including ISO 13485, FDA 21 CFR 820, and the Quality Management System Regulation (QMSR).

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and company quality systems and procedures to optimize product development, internal and external manufacturing, and product distribution.

• Investigate moderately complex manufacturing product quality and compliance issues, including:
• Investigating product risk assessments (PRAs) and customer complaints related to manufacturing.
• Managing site NCRs, CAPAs, Engineering Change Requests (ECRs), and audit observations for production processes prior to final product release.
• Analyzing findings and developing recommendations and reports.
• Providing technical support during internal and external audits.
• Oversee product release activities, assess and disposition materials on hold through the Material Review Board (MRB), and manage material quality control.
• Review and approve equipment validations and asset management activities.
• Collaborate with engineering teams to support successful product and process transfers.
• Develop, update, and maintain technical content for risk management files, including reviewing and revising Process Failure Mode and Effects Analyses (pFMEAs) in collaboration with cross-functional teams.
• Develop training materials and manufacturing documentation (such as work instructions) to facilitate effective knowledge transfer for production processes.
• Support:
• Process validation activities, including leading or supporting validation efforts.
• Sustaining Quality Engineering functions such as Quality Metrics reviews, Material Review Boards, Quality Control, and continuous improvement initiatives.

• Bachelor's degree in Engineering or a related technical field required.

• Minimum of 2 years of Quality Engineering experience in a manufacturing environment.

• Experience managing NCRs, CAPAs, ECRs, and quality investigations.
• Knowledge of ISO 13485, FDA 21 CFR 820, and QMSR requirements.
• Strong documentation, communication, interpersonal, and relationship management skills.
• Basic understanding of statistical analysis techniques.
• Experience working with laboratory or industrial manufacturing equipment.
• Solid understanding of engineering principles, manufacturing processes, and quality systems.
• Strong analytical, organizational, problem-solving, and critical thinking skills.
• Knowledge of process validation and risk management methodologies.
• High attention to detail and commitment to quality.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to work effectively within cross-functional teams and collaborate with vendors and stakeholders.
• Strong professional communication skills across all organizational levels.
• Commitment to following all company policies, Environmental Health & Safety (EHS) requirements, and workplace safety protocols.