Quality Engineer – Quality Operations
Duration: 6 months+
Work Location: 250 Schilling Circle, Hunt Valley Maryland 21031
Onsite – 5 Days a Week
Pay: $55.00 - $57.90/hr on w2.
Education: Bachelor's Degree Required
Experience: 5+ Years in Quality / Quality Operations
Job Summary
We are seeking an experienced Quality Engineer to support Quality Operations at an instrument manufacturing facility. The ideal candidate will be responsible for reviewing and assessing Quality Notifications, Customer Complaints, Deviations, Waivers, and other cGMP-related activities for assigned product lines.
This role will ensure manufacturing operations comply with internal Quality Policies, FDA regulations, GMP requirements, and applicable ISO standards. The candidate will also support complaint investigations, manufacturing issue resolution, and continuous quality improvement initiatives.
Key Responsibilities
- Review, assess, and manage Quality Notifications, Customer Complaints, Deviations, Waivers, and other cGMP-related activities.
- Oversee manufacturing operations to ensure compliance with established quality standards and regulatory requirements.
- Ensure quality documentation, procedures, and records are properly maintained, updated, and compliant with internal Quality Policies.
- Conduct customer complaint investigations and support root cause analysis.
- Assist in investigating manufacturing issues and provide technical input for corrective and preventive actions (CAPA).
- Provide quality-related data, analysis, and recommendations to support technical projects and process improvements.
- Ensure compliance with FDA regulations, Good Manufacturing Practices (GMP), and applicable ISO Quality System standards.
- Apply statistical methods and quality tools to identify trends, evaluate performance, and support decision-making.
- Collaborate with cross-functional teams to resolve quality issues and improve manufacturing processes.
Required Qualifications
- Bachelor's degree in a related technical or scientific discipline.
- 5+ years of experience in Quality, Quality Engineering, or Quality Operations.
- Working knowledge of Quality Management Systems (QMS), cGMP, FDA regulations, and ISO standards.
- Experience handling customer complaints, deviations, waivers, quality notifications, and manufacturing investigations.
- Understanding of statistical methods and statistical application software.
- Proficiency in Microsoft Office applications and the ability to learn new software systems.
- Strong analytical, problem-solving, documentation, and organizational skills.
- Excellent verbal and written communication skills.
- Ability to work independently with minimal supervision and collaborate effectively within cross-functional teams.
- Ability to manage multiple priorities while maintaining accuracy and attention to detail.
Preferred Qualifications
- Master's degree in a relevant discipline.
- Professional certifications such as CQA, CQE, SQE, CQM, or Six Sigma.
- Project management experience.
- Experience in regulated manufacturing or instrument manufacturing environments.
Preferred Educational Background
- Mechanical Engineering
- Electrical Engineering
- Industrial Engineering
- Biological Sciences
- Chemistry
- Computer Science
- Other related technical or scientific disciplines
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