Quality Engineer - Validation

The Quality Engineer II, Validation is responsible for supporting and maintaining Quality Systems within a regulated manufacturing environment, with a primary focus on validation writing, execution, and compliance. This role ensures consistent application of quality standards, supports continuous improvement initiatives, and partners cross-functionally to support manufacturing operations, product quality, and regulatory compliance.

Responsibilities

• Develop, implement, and maintain Quality System procedures, Standard Operating Procedures (SOPs), and quality policies.
• Lead and execute validation activities, including change validations and recurring process and equipment qualifications.
• Monitor, trend, and analyze quality indicators for purchased materials, manufactured products, and distributed components.
• Assess Critical to Quality (CTQ) parameters and perform risk assessments to support product quality, process predictability, and sound decision-making.
• Apply statistical tools and data analysis techniques to identify root causes, resolve quality issues, and implement effective corrective actions.
• Initiate and support Corrective and Preventive Actions (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 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, regulatory 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.

Required Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, Engineering, or another related scientific or technical field.
• At least 2 years of experience in Quality, Scientific Operations, Engineering, or a related regulated industry environment.
• Basic knowledge and understanding of FDA regulations and applicable quality standards, including 21 CFR Part 820, ISO 13485, and ISO 14971.
• Ability to manage multiple priorities, develop action plans, and drive execution of quality-related activities and changes.
• Experience leading or supporting process control, supplier quality, and continuous improvement initiatives using statistical techniques and tools such as statistical sampling, SPC, and Six Sigma.
• Strong knowledge of root cause analysis, risk assessment, failure analysis, and project management methodologies.
• Strong technical writing and communication skills, with the ability to communicate clearly and effectively to different audiences.
• Ability to present information and express points of view effectively in individual, group, and formal presentation settings.
• Strong listening, problem-solving, and decision-making skills.
• Ability to analyze moderately complex data using systematic analytical approaches

Preferred Qualifications

• Experience with technical writing and managing process and test method validations.
• Experience in a medical device, pharmaceutical, biotechnology, or other regulated manufacturing environment.
• Experience supporting manufacturing quality systems and validation programs.
• Familiarity with automated manufacturing, filling, packaging, or related production systems is a plus.

Base Salary: $80,000–$90,000 USD