Quality Engineer - Medical Devices | Process & Compliance

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

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).