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
