Senior Quality Engineer: CAPA, QA & Validation Leader

Evergen; West Lafayette (IN); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Relocation bonus offered

Job summary

A leading contract development organization is seeking a Quality Assurance professional located in West Lafayette, IN. The ideal candidate will support product development processes, lead investigations for nonconformances, and facilitate supplier qualifications. A bachelor’s degree in Engineering along with a minimum of 6 years of relevant experience is required. The role includes responsibilities such as CAPA activities, risk management, and process improvement initiatives, providing a collaborative working environment.

Qualifications

• Minimum of 6 years of quality or engineering experience. Education may be substituted if the required experience is not met.

Responsibilities

• Develop a strong network of cross‑functional colleagues to support the Quality Assurance function.
• Support product development processes and collaboration with core teams.
• Lead investigations for product nonconformances and document findings.
• Participate in risk assessment and review of nonconforming products.
• Perform CAPA activities including root cause analysis.
• Support supplier qualification activities and audits.
• Support validation activities by reviewing protocols and reports.
• Ensure proper change control by initiating change plans.
• Directly support quality systems and process improvement initiatives.
• Perform other assignments as directed.

Skills

Excellent verbal and written communication

Technical writing

Problem-solving methodologies

Microsoft Office Suite proficiency

Experience with Quality Management System software

Investigations experience

Education

Bachelor’s degree in Engineering or a relevant technical discipline

Job description

A leading contract development organization is seeking a Quality Assurance professional located in West Lafayette, IN. The ideal candidate will support product development processes, lead investigations for nonconformances, and facilitate supplier qualifications. A bachelor’s degree in Engineering along with a minimum of 6 years of relevant experience is required. The role includes responsibilities such as CAPA activities, risk management, and process improvement initiatives, providing a collaborative working environment.