Quality Engineer

Description Overview

Assists with investigations and documentation of quality related complaints, inquiries, requests for assistance from consumers, customers, regulatory agencies, and 3rd party product assessments concerning Perrigo drug and device products per regulatory requirements

Scope of the Role

• Independently scope, plan, and lead investigations related to customer complaints for PNY products, ensuring timely and effective resolution.
• Support the maintenance and reporting of the CAPA management system by tracking corrective actions, verifying implementation of corrections, and evaluating the effectiveness of corrective and preventive actions.
• Assist in the administration of a risk-based supplier qualification and assessment program for both new and existing PNY material suppliers.
• Maintain and report supplier and audit management data, including forecasting and coordinating external audits of material suppliers and contract laboratories.
• Support the development, maintenance, and reporting of supplier performance metrics, including the preparation and analysis of supplier scorecards.
• Assist with the Annual Product Review (APR) process by preparing reports, analyzing data, and coordinating follow-up activities as required.
• Identify, assess, and implement risk mitigation plans, including conducting "for-cause" supplier assessments when necessary.
• Provide on-site support to Corporate Consumer Affairs, as needed, to facilitate the investigation and resolution of customer complaint inquiries.

Experience Required

• Knowledge and Skills:

  The incumbent must possess a comprehensive understanding of pharmaceutical manufacturing, packaging, and quality control systems. A strong working knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, and pharmaceutical manufacturing processes is required. The role demands excellent analytical and troubleshooting abilities, including the capacity to interpret regulatory requirements and effectively apply them to company policies, procedures, and quality systems.

  Exceptional written and verbal communication skills are essential, along with strong interpersonal skills and the ability to collaborate effectively with personnel at all organizational levels. Proven technical writing capabilities are also required.

  A Bachelor's degree in a scientific, engineering, or other technical discipline is required. Candidates must demonstrate a solid understanding of Quality Engineering principles and practices. Prior experience in quality assurance, quality control, inspections, engineering, or research and development within the pharmaceutical, biotechnology, or chemical manufacturing industries is required.

  A minimum of two to five years of experience in a manufacturing environment applying quality engineering and quality systems principles is preferred. Proficiency in computer applications, including Microsoft Office, TrackWise, and SAP, is required. Experience with statistical analysis tools and software packages for data trending and process improvement is highly desirable.

  Essential Functions:

  The incumbent must possess statistical analysis proficiency and provide coaching to all levels within the organization. The incumbent must demonstrate the understanding of much of the Quality Engineering Body of Knowledge or be working toward Certification in Quality Engineering. The incumbent must be able to work independently on multiple concurrent projects and meet project deadlines. The incumbent must be able to read and interpret technical and regulatory documentation in hard copy and electronic formats. The incumbent must possess sufficient mobility to enter and maneuver in manufacturing, packaging and laboratory areas. The incumbent must be able to work a minimum of 40 hours per week.