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.