Quality Engineer

Intellectt INC

Role:Quality Engineer II
Location: Columbia, MD
Rate: $35-40/hr W2

About the Role
We are seeking a Quality Engineer II to support quality and manufacturing operations at a growing medical device manufacturing site. This is a great opportunity to work cross-functionally with engineering and operations teams on high-impact quality systems initiatives, with strong potential for the role to extend into a long-term position.

What You'll Do
Maintain and facilitate critical quality management systems, including change management, calibration, preventive maintenance, environmental monitoring, and validation programs
Lead and participate in cross-functional problem-solving, investigation, and development teams
Author, edit, and provide guidance on quality documentation, including validation protocols and reports, product and material specifications, design and development documentation, SOPs, and quality investigations
Investigate quality events using a systematic, data-driven approach to determine root cause and corrective/preventive actions
Support development of statistically based sampling plans for product testing, inspections, and validations; provide statistical analysis to support quality documentation
Prepare monthly and quarterly trending, analysis, and Statistical Process Control (SPC) reports; support the Quality Management Review process
Support the launch of new or improved products and processes, and facilitate technology transfer from development to commercialization
Manage changes to device design and manufacturing procedures for commercialized products
Participate in FDA inspections, ISO certification and surveillance audits, and customer audits

Role Breakdown
40% Change management: quality impact assessments, change control execution, strategic planning support
25% Quality investigations: root cause analysis, CAPA, event documentation
15% Development, review, and approval of quality records (SOPs, plans, protocols, reports)
10% Support of critical control programs (calibration, PM, environmental monitoring, change management)
5% Maintaining current knowledge of applicable regulations and standards
5% Participation in internal and external audits

What You Bring
Bachelor's degree in a relevant field (Master's preferred); equivalent experience considered in lieu of formal education
Technical specialization in change management and data integrity, systems development/validation, or data integration and trending
GMP experience in a controlled, regulated manufacturing environment
Working knowledge of FDA regulations (21 CFR Part 820, 21 CFR Part 11), ISO 13485, and international medical device regulations
Understanding of statistically based sampling plans and analytical tools, with a track record of data-driven decision-making
Strong organizational, communication, and project management skills
Proficiency with electronic quality management systems, ERP systems, and Microsoft Office
Coding/scripting experience or complex data-system validation experience is a plus
ASQ or RAPS certification preferred; non-certified candidates expected to pursue one within the first year

Why This Role
High-visibility position supporting core quality systems at an active medical device manufacturing site
Broad scope across change management, validation, investigations, and audits
Strong potential for extension into a longer-term or permanent placement
Direct collaboration with engineering, operations, and quality leadership

Apply

Vacancy posted 2 days ago

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