Job Title: Manager, Quality Engineering 

Work Location: Bucks County, Pennsylvania

Summary:

Seeking a Manager, Quality Engineering to oversee the development, validation, and maintenance of manufacturing and quality management systems, ensuring compliance with internal procedures, customer requirements, and regulatory standards for products and components.

Responsibilities:

• Lead and document investigations for corrective and preventive actions, including customer complaints, root cause analysis, and technical support.
• Manage supplier corrective action requests, communicate with suppliers regarding non-conformances, and oversee supplier changes.
• Support product development and commercial products by reviewing and approving specifications, drawings, and validation protocols.
• Utilize statistical software to analyze data, develop statistical methods, and design experiments for process and product improvement.
• Conduct risk management activities using tools such as pFMEAs and support the implementation of sampling, inspection, and testing methods.
• Review and approve validation and qualification documents for compliance with internal procedures and regulatory standards.
• Supervise, coach, and develop quality engineering staff, including hiring, performance reviews, and career planning.
• Participate in departmental budgeting, monitor expenses, and support audits and strategic accounts as needed.

Qualifications:

• Bachelor’s degree in Engineering, Quality, or Life Sciences.
• 5-7 years of relevant experience, including co-op experience.
• Minimum 3–5 years of direct managerial or supervisory experience, including hiring, coaching, performance management, and team development.
• Experience in life sciences/GMP industry in Quality Assurance, Quality Engineering, Validation, Product Development, Process Engineering, or Manufacturing Engineering.
• Knowledge of regulatory standards such as ISO 13485; familiarity with FDA Regulation 21 CFR Part 820 preferred.
• Strong analytical, problem-solving, and risk analysis skills; demonstrated project organizational skills.
• Proficiency in MS Office Suite and statistical software (e.g., Minitab); knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management, and process control.
• Excellent written and verbal communication skills, customer service focus, and professionalism.
• Ability to read, analyze, and interpret scientific/technical journals, financial reports, and legal documents; respond to inquiries from customers and regulatory agencies.
• Demonstrated ability to lead cross-functional teams, independently prioritize and execute projects, and supervise staff.
• Strong supervisory skills and ability to participate in or lead audits.

Published Category: Quality & Validation