Quality Engineering Manager

Quality Engineering Manager at ClinLab Solutions Group Quality Engineering Manager at ClinLab Solutions Group in Quakertown, Pennsylvania Posted in 1 day ago.

Type:

full-time

Job Description:

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