Senior Quality Engineer

Position Title: Sr. Quality Engineer

Location: Baltimore, MD (Area)

Department: Quality Assurance

Reports To: Director of Quality

The Ideal Candidate will have 10 YOE focused on ISO quality within a manufacturing environment.

Compensation:

• Highly competitive salary bonus STI
• Full Benefits, Medical, Dental, Vision, 401K Matching, Life
• Outstanding company culture and vertical career mobility

Quality Systems & Compliance

• Manage and maintain quality documentation for the Quality Management System (QMS), including procedures, work instructions, and audit materials.
• Ensure organizational compliance with applicable quality standards such as ISO 9001, ISO 13485, and AS9100.
• Participate in and support internal, customer, and third-party audits, including supplier audits and regulatory reviews.

Inspection & Testing

• Develop and execute inspection protocols, sampling plans, and test methodologies.
• Perform and oversee First Article Inspections (FAI), in-process inspections, and final product validations.
• Monitor inspection outcomes to ensure product conformance and process reliability.

Data Analysis & Reporting

• Utilize tools like Statistical Process Control (SPC) to collect, interpret, and act on quality data.
• Create dashboards, reports, and presentations to share performance trends and support decision-making.
• Identify areas of risk and opportunity using quantitative and qualitative methods.

Corrective Actions & Process Improvements

• Lead Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA).
• Apply Lean, Six Sigma, and other CI techniques to drive manufacturing process improvement.
• Conduct Failure Modes and Effects Analysis (FMEA) and risk assessments to support proactive quality planning.

Cross-Functional & Supplier Collaboration

• Partner with Engineering, Manufacturing, and Supply Chain teams to translate designs and specifications into practical solutions.
• Collaborate with suppliers to validate component quality and drive continuous improvement in vendor processes.
• Support supplier selection and performance evaluations with quality criteria and insights.

Training & Development

• Educate internal teams on quality procedures, tools, and expectations.
• Foster a culture of accountability, precision, and continuous learning within the organization.

New Product Development

• Support APQP activities and oversee the Preproduction Part Approval Process (PPAP).
• Engage early in design and process validation phases to ensure quality is built into the product lifecycle.

Desired Skills and Experience

Education:

• Bachelor’s degree in Engineering, Quality Management, or a related STEM field is required.
• Master’s degree in Engineering or a related discipline is preferred.
• Minimum 10 years of quality engineering experience in a manufacturing environment.
• Demonstrated success leading quality initiatives within regulated or ISO-certified environments.
• Experience with root cause methodologies, SPC, Lean, Six Sigma, and process validation.
• Proficient in Microsoft Office Suite and quality analysis software/tools.
• Strong understanding of QMS systems, statistical analysis, and continuous improvement methodologies.
• Skilled in risk assessments, data visualization, and technical documentation.