MedTech Quality Validation Engineer II

Regulatory Jobs; Cockeysville (MD); On-site; USD 76,000 - 121,000; Full time

Job summary

BD is a global medical technology company seeking a Quality Engineer II, Validation to support and maintain Quality Systems across Media manufacturing plants. The role focuses on validation writing, execution, and compliance, partnering with cross-functional teams to drive quality and regulatory adherence.

The candidate will lead validation activities, apply statistics, manage CAPAs, and participate in continuous improvement to ensure product quality and manufacturing efficiency.

Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, or other related science field.
• 2 years experience in Quality, Scientific Operations, or Engineering.
• Experience in technical writing and managing process and test method validations.
• Experience in a medical device or pharmaceutical manufacturing facility.

Responsibilities

• Develop, implement, and maintain Quality System procedures, SOPs, and quality policies.
• Lead and execute validation activities, including change validations and recurring process/equipment qualifications for Media plants and IDAST.
• Monitor, trend, and analyze quality indicators for purchased materials, manufactured products, and distributed components.
• Assess CTQ parameters and perform risk assessments to support product quality, process predictability, and decision-making.
• Apply statistical tools and data analysis techniques to identify root causes, resolve quality issues, and implement effective corrective actions.
• Initiate and support CAPAs, including leading investigations and corrective action activities when required.
• Support process control initiatives and promote consistent manufacturing practices across operations.
• Identify and recommend continuous improvement opportunities to enhance product quality, operational efficiency, and compliance.
• Manage day-to-day Quality Management (QM) Engineering activities for assigned products and operational projects.
• Partner with manufacturing, engineering, and cross-functional teams to support product launches, process improvements, and quality initiatives.
• Ensure consistent implementation and application of Quality Systems for both new and existing product lines.
• Maintain compliance with FDA regulations, ISO standards, and other applicable quality and regulatory requirements.
• Support quality-related activities including change controls, product quality notifications, post-market activities, IVDR compliance, and customer complaint investigations.
• Utilize enterprise systems and quality tools to drive compliance, documentation accuracy, and process efficiency.
• Serve as a subject matter expert (SME) during internal and external audits, as needed.
• Foster collaborative and inclusive working relationships across departments that support Media manufacturing operations

Skills

FDA 21 CFR 820

ISO 13485/14971

Change management

Statistical tools

Six Sigma

Root cause analysis

CAPA management

Data analysis

Quality systems

Education

Bachelor's degree in Biological Sciences, Chemistry, or related science

Job description

BD is a global medical technology company seeking a Quality Engineer II, Validation to support and maintain Quality Systems across Media manufacturing plants. The role focuses on validation writing, execution, and compliance, partnering with cross-functional teams to drive quality and regulatory adherence.

The candidate will lead validation activities, apply statistics, manage CAPAs, and participate in continuous improvement to ensure product quality and manufacturing efficiency.