Quality Assurance Engineer II

United Pharma; Town of Texas (WI); On-site; USD 75,000 - 105,000; Full time

Job summary

United Pharma is seeking a Quality Assurance Engineer II to join our manufacturing quality team. The ideal candidate will bring experience in quality systems, process improvement, and CAPA to drive product quality and compliance.

The role requires collaboration across engineering and production to implement robust quality controls, lead audits, and support validation activities. Strong problem-solving skills and proficiency with MS Office are essential.

Qualifications

• Bachelor's degree in mechanical engineering or related discipline.
• Experience in QA/Quality Engineering within a manufacturing environment.
• Knowledge of quality systems and standards such as ISO 9001, ASQ, ISO 14001, QS 9100, or similar.
• Experience with audits, root cause analysis, corrective actions, and process validation.
• Strong problem-solving and analytical skills.
• Proficiency in Microsoft Office, including Excel and Word.

Responsibilities

• Develop, maintain, and implement quality requirements and standards.
• Serve as the primary quality resource for problem identification, resolution, and continuous improvement activities.
• Support equipment, process, and test method qualification/validation projects.
• Design and implement process controls, testing, inspection, and quality improvement methods.
• Develop and maintain quality documentation, reports, and quality plans.
• Participate in internal and external quality audits.
• Investigate quality issues, perform root cause analysis, and implement corrective actions (CAPA).
• Monitor quality trends and report key quality metrics.
• Support process certification and compliance initiatives.
• Drive product and process improvements to enhance customer satisfaction.

Skills

Quality Assurance

Root cause analysis

Problem solving

Analytical skills

Process improvement

CAPA

Audits

Documentation

MS Office

Excel

Word

Education

Bachelor's degree in mechanical engineering

Tools

ISO 9001

ASQ

ISO 14001

QS 9100

Job description

A leading global pharmaceutical and medical technology company to hire a Quality Assurance Engineer II . This is an exciting opportunity for a quality professional with experience in manufacturing, process improvement, audits, and quality systems.

Key Responsibilities

• Develop, maintain, and implement quality requirements and standards.
• Serve as the primary quality resource for problem identification, resolution, and continuous improvement activities.
• Support equipment, process, and test method qualification/validation projects.
• Design and implement process controls, testing, inspection, and quality improvement methods.
• Develop and maintain quality documentation, reports, and quality plans.
• Participate in internal and external quality audits.
• Investigate quality issues, perform root cause analysis, and implement corrective actions (CAPA).
• Monitor quality trends and report key quality metrics.
• Support process certification and compliance initiatives.
• Drive product and process improvements to enhance customer satisfaction.

Required Qualifications

• Bachelor's degree in mechanical engineering or a related engineering discipline.
• Experience in Quality Assurance/Quality Engineering within a manufacturing environment.
• Knowledge of quality systems and standards such as ISO 9001, ASQ, ISO 14001, QS 9100, or similar.
• Experience with audits, root cause analysis, corrective actions, and process validation.
• Strong problem-solving and analytical skills.
• Proficiency in Microsoft Office, including Excel and Word.