Quality Engineer, Supplier Quality - Pharmaceutical Manufacturing

Quality Engineer, Supplier Quality - Pharmaceutical Manufacturing

Yoh is hiring a Quality Engineer, Supplier Quality for our pharmaceutical manufacturing client in Noblesville, Indiana
.

This is a great opportunity for a quality professional with experience in supplier quality, QA systems, GMP manufacturing, audits, CAPA, deviations, change control, vendor management, or document control to support a regulated pharmaceutical manufacturing site. The role will support the site Supplier Quality Program and help ensure suppliers, vendors, materials, documentation, and related quality activities remain compliant with applicable regulatory requirements and internal procedures.

The Quality Engineer, Supplier Quality will assist with supplier evaluations, supplier complaints, Quality Agreements, vendor change assessments, internal audits, corrective action follow-up, document management, and inspection readiness.

Location: Noblesville, IN

Schedule: Monday-Friday, 7:30 AM-4:00 PM

Compensation: Up to $75,000 annually, depending on experience

Employment Type: Direct Hire / Permanent

• Support the site Supplier Quality Program in compliance with applicable regulations, cGMP requirements, and internal procedures.
• Maintain operational compliance with applicable US and international regulatory agencies and guidelines, including FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, and cGMP requirements.
• Conduct supplier evaluations, including supplier questionnaires, risk-based assessments, and supplier audits as applicable.
• Issue supplier complaints and drive timely resolution, including supplier corrective action follow-up.
• Develop, review, and maintain Supplier Quality Agreements.
• Perform initial assessments of vendor changes, route changes for functional review, and track actions through completion.
• Generate or review Change Controls related to SOPs, Standard Test Methods, Data Sheets, and other controlled documentation.
• Support or serve as lead investigator for exceptions, deviations, supplier quality issues, and other quality events.
• Apply quality tools such as FMEA, Fishbone, 5 Why, Risk Analysis, and root cause analysis tools to support investigations and continuous improvement initiatives.
• Participate in internal audits and assess corrective action recommendations.
• Support FDA and other regulatory inspections, customer audits, and site audit-readiness activities.
• Perform statistical analysis of quality or laboratory data in support of investigations, cost savings, and continuous improvement initiatives.
• Execute assigned project tasks in accordance with established timelines.
• Perform filing, scanning, and document management activities as needed.
• Maintain current knowledge of applicable regulations related to microbiology, chemistry, cGMPs, and pharmaceutical quality systems.
• Ensure a safe and quality-focused work environment through training, awareness, and compliance with site procedures and regulatory guidelines.

• Bachelor of Science degree in Life Sciences, Engineering, or a related technical discipline required; equivalent experience may be considered.
• 3+ years of quality experience in a pharmaceutical, biotechnology, medical device, or other FDA/ISO-regulated manufacturing environment.
• Experience with supplier quality, supplier evaluations, supplier complaints, supplier corrective actions, vendor changes, supplier audits, or Quality Agreements strongly preferred.
• Strong understanding of regulated quality systems and cGMP requirements.
• Working knowledge of cGMP guidelines and their application in a controlled aseptic manufacturing environment preferred.
• Experience with quality systems such as Change Control, CAPA, Deviations, Complaint Investigations, Internal Auditing, and Document Management.
• Experience using statistical tools, data analysis, trending, or quality metrics in support of investigations or continuous improvement.
• Proficiency with Microsoft Office applications, including Excel.

• Pharmaceutical manufacturing, sterile manufacturing, aseptic manufacturing, radiopharmaceutical, biotechnology, or medical device manufacturing experience.
• Supplier qualification, supplier performance monitoring, vendor change assessment, or supplier audit experience.
• Experience supporting FDA inspections, customer audits, internal audits, or regulatory inspection readiness.
• Experience using root cause analysis tools such as 5 Why, Fishbone, FMEA, Pareto analysis, or risk assessment tools.
• Experience with controlled documents, SOPs, quality records, and electronic quality systems.

• Strong problem-solving, decision-making, verbal communication, and written communication skills.
• Ability to prioritize work based on business needs in a fast-paced regulated manufacturing environment.
• Ability to exercise independent judgment in planning, organizing, and completing assigned tasks.
• Strong documentation skills and attention to detail.
• Ability to work cross-functionally with Quality, Manufacturing, Supply Chain,…