Senior Design Quality Engineer

Responsibilities

• Lead and support failure investigations, root cause analysis, and problem-solving activities for non-conforming products and manufacturing processes.
• Review and approve new or modified design and process specifications, including product performance requirements, test methods, and process validation documentation.
• Contribute to and support the successful execution of quality engineering programs and project initiatives.
• Independently analyze issues and develop effective solutions to complex quality and process challenges.
• Provide guidance and direction to team members as needed.
• Partner closely with manufacturing sites to address quality concerns and drive continuous improvement.
• Serve as a quality engineering representative on cross-functional teams.
• Define and maintain product control strategies to ensure consistent product quality and compliance.
• Lead risk management activities throughout the product lifecycle.
• Ensure compliance with design control requirements and regulatory expectations.
• Plan, execute, and support process validation activities.
• Support supplier qualification efforts, including risk classification assessments and product quality evaluations.
• Assess and improve test methods used in product and process development projects.
• Evaluate customer requirements to determine applicable quality and regulatory standards.
• Review and approve the release of customer samples during product development activities.
• Conduct and participate in quality functional reviews.
• Ensure adherence to global Pharmaceutical Systems procedures, standards, and Quality Engineering practices.
• Provide support during internal audits, customer audits, and regulatory inspections, including the implementation of corrective actions.
• Drive continuous improvement initiatives focused on product quality, customer satisfaction, and market competitiveness.
• Support new customer onboarding activities, including pre-feasibility and feasibility assessments.
• Provide technical expertise, problem-solving support, and remediation guidance to manufacturing sites to prevent or minimize quality issues.
• Collaborate with customer-facing teams to address quality and product-related matters.
• Assist with supplier and internal quality system audits to evaluate the effectiveness of the Quality Management System and compliance with Good Manufacturing Practices (GMP).

• BS degree in Engineering, or other scientific discipline and 5 years relevant experience (Medical Device/ Pharmaceutical) OR Masters Degree in Engineering, or other scientific discipline and 3 years relevant experience (Medical Device/ Pharmaceutical)

• Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP
• Knowledge of design control principles.
• Good understanding of statistical methods for Quality Assurance
• General working knowledge of the six-sigma process methodology
• Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
• Knowledge and experience in manufacturing
• Excellent problem solving and analytical skills
• Ability to handle multiple projects simultaneously in an unsupervised environment.
• Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.