Quality Engineer

United Pharma; Indiana; On-site; USD 85,000 - 110,000; Full time

Job summary

United Pharma in the United States seeks a Quality Engineer to ensure product quality and process control during development and sustaining activities. You will partner with Operations, Engineering, Metrology, and PM for continuous improvement and robust control strategies to ensure audit readiness.

Role requires problem-solving skills to drive compliant process improvements and alignment with regulatory requirements (ISO 13485, FDA QSR).

Qualifications

• Bachelor’s degree in Engineering (Mechanical or Biomedical preferred).
• Minimum 5 years’ experience as quality or manufacturing engineer.
• Experience in manufacturing medical devices or aerospace.
• Working knowledge of GMP environments.
• Familiar with ISO 13485 and 21 CFR 820 or NADCAP quality systems.
• Strong quality control and quality assurance fundamentals.
• Experience with validation, risk management, and process control.
• Knowledge of CAPA, complaint handling, and nonconformance/deviation processes.
• Solid statistical and data analysis skills (capability, SPC).

Responsibilities

• Assist in development and maintenance of in-process inspection plans, control plans, and sampling strategies.
• Define and monitor CTQ characteristics with appropriate inspection methods.
• Identify process variation and implement real-time process control improvements.
• Author validation plans and summaries; support qualification and protocol development.
• Support test method validation activities for measurement and attribute testing systems.
• Ensure alignment of product specifications, drawings, and process requirements with stakeholders.
• Support and drive CAPA, nonconformance, and complaint activities.
• Participate in audits and prepare manufacturing records and follow-up actions.
• Lead PFMEA development and maintenance for NPI and existing processes.
• Identify process risks and implement preventive controls and mitigations.
• Facilitate investigations using root cause tools (5 Whys, Fishbone, etc.).
• Support supplier qualification and supplier management.

Skills

Quality engineering

Process control

Root cause analysis

Statistical analysis

CAPA

Education

Bachelor’s degree in Engineering

Tools

ISO 13485

21 CFR 820

NADCAP

Job description

The Quality Engineer is responsible for ensuring product quality and process control throughout the development of new and sustaining processes. This role ensures that manufacturing processes are capable, controlled, and compliant with applicable regulatory requirements (e.g., ISO 13485, FDA QSR), while supporting successful product launches and sustained production performance.

The Quality Engineer partners cross-functionally with Operations, Engineering, Metrology, and Program Management for continuous improvement as well as develop robust process control strategies that ensure consistent product quality and audit readiness. This role also works closely with customers and suppliers to ensure compliant processes and requirements are established and upheld. The Quality Engineer must have a problem-solving mindset that drives toward compliant and effective process and process improvement.

Key Responsibilities

• Assist in development, implementation, and maintenance of in-process inspection plans, control plans, and sampling strategies for manufacturing operations.
• Define and monitor critical-to-quality (CTQ) characteristics, ensuring appropriate inspection methods and acceptance criteria are applied.
• Partner with operations and engineering to identify process variation and implement real-time process control improvements.
• Author validation plans and summary reports while also supporting qualification and protocol development throughout the validation lifecycle.
• Support and drive test method validation activities for measurement and attribute testing systems.
• Collaborate with customers and internal stakeholders to ensure alignment of product specifications, drawings, and process requirements.
• Support and drive complaint and nonconformance activities.
• Support and drive CAPA activities to address systemic issues and prevent recurrence.
• Participate in internal, customer, and regulatory audits, including preparation of manufacturing records and follow‑up actions.
• Author and develop key quality processes to ensure compliant, robust, and effective execution.
• Lead or support PFMEA development and maintenance for NPI and existing processes.
• Identify process risks and implement preventive controls and mitigation strategies.
• Facilitate or lead investigation of nonconformances, deviations, and CAPA, utilizing root cause analysis tools (5 Whys, Fishbone, etc.).
• Lead or support supplier qualification and supplier management.

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical or Biomedical preferred)
• Minimum 5 years’ experience as quality (or manufacturing) engineer
• Experience in manufacturing medical devices (or aerospace)
• Working knowledge of GMP environment
• Working knowledge of ISO 13485 and 21 CFR 820 or similar QMS standards and regulation (i.e. NADCAP)
• Strong working knowledge of both Quality Control and Quality Assurance principles
• Working knowledge of validation, risk management, and process control
• Working knowledge of CAPA, complaint, and nonconformance/deviation processes
• Strong statistical and data analysis skills (process capability, statistical process control, etc.)