Quality Engineer I - Manufacturing

Position Summary

The Quality Engineer I provides quality support to ensure compliance, product quality, and continuous improvement. This role leads investigations, CAPAs, complaint trend analysis, risk assessments, and validation activities while partnering with cross-functional teams to resolve quality issues and improve processes.

Key Responsibilities

Lead root cause investigations for nonconformances, complaints, and quality events.Manage CAPAs, change controls, and quality improvement initiatives.
Serve as the Quality representative for Material Review Board (MRB) meetings.
Conduct risk assessments and develop mitigation plans to support Quality and Production KPIs.
Support equipment qualification, installation, and test method validation activities.
Audit manufacturing processes, suppliers, and raw materials to ensure quality standards are met.
Collaborate with Engineering, Manufacturing, and Operations teams to identify and mitigate quality risks.
Analyze quality data and complaint trends to drive continuous improvement.

Qualifications

Required

Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.
2+ years of experience in Quality Engineering, Quality Assurance, Manufacturing, or a related field.
Experience with root cause analysis, investigations, and CAPA management.
Strong analytical, problem-solving, and communication skills.

Preferred

Experience in a regulated industry (medical device, pharmaceutical, or manufacturing).
Experience with root cause analysis, nonconformance, and change control processes.
ASQ, Six Sigma, or other quality-related certifications.


Knowledge & Skills

Quality systems and regulatory compliance.
Risk management and continuous improvement methodologies.
Ability to manage multiple priorities and work effectively across functions.
Strong technical writing and documentation skills.

Additional Information

Occasional travel may be required.
Ability to work in both office and manufacturing environments.
Must be able to occasionally lift up to 20 pounds.

Why Join Us?Join a collaborative team where you'll have the opportunity to solve complex quality challenges, drive continuous improvement, and make a direct impact on product quality and customer satisfaction.

Salary Range: $85,300 - $95,300