Quality Engineer (Bronx, NY, US, 10457)

Biopharma Careers; Bronx (ID); On-site; USD 85,000 - 125,000; Full time

Job summary

Perrigo is seeking a Quality Engineer to assist investigations and documentation of quality-related complaints and regulatory inquiries for Perrigo drug and device products. You will independently scope and lead investigations for customer complaints, support CAPA tracking, and contribute to supplier qualification programs.

The role emphasizes cGMP knowledge, data analysis, and collaboration across functions.

Qualifications

• Bachelor's degree in science, engineering, or technical discipline required.
• Solid understanding of quality engineering principles and practices.
• Experience in pharmaceutical manufacturing, QA/QC, inspections, or R&D preferred.

Responsibilities

• Lead investigations related to customer complaints and regulatory inquiries.
• Support CAPA management system: track actions, verify corrections, evaluate effectiveness.
• Assist supplier qualification and assessment program for new and existing material suppliers.
• Maintain and report supplier performance metrics and scorecards.
• Support APR process by preparing reports and coordinating follow-ups.
• Identify and implement risk mitigation plans; conduct for-cause supplier assessments when needed.

Skills

Quality Engineering

cGMP

FDA regulations

Analytical troubleshooting

Regulatory compliance

Communication skills

Education

Bachelor's degree in a scientific, engineering, or technical discipline

Tools

TrackWise

SAP

Microsoft Office

Job description

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All . We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone , we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

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, analysing 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.

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo