Quality Assurance Engineer

International Executive Service Corps; Indiana (PA); On-site; USD 85,000 - 110,000; Full time

Job summary

International Executive Service Corps is seeking a Quality Assurance professional to lead non-conformance investigations and drive corrective actions within medical device and pharmaceutical contexts. The role requires strong English, a life sciences or engineering degree, and 3+ years of QA experience.

You will coordinate cross-functional teams, analyze trends, and support audits while advancing supplier quality and continuous improvement initiatives across the organization.

Qualifications

• Bachelor's degree in Engineering or Life Sciences or equivalent.
• Strong English skills, both written and spoken.
• French and/or German, both written and spoken.
• Good IT knowledge in MS Office.
• Excellent organization and communication skills.
• Flexible and adaptable to change with ability to work under pressure.
• Responsible, operate with integrity and teamwork.
• Learning attitude and logical approach.
• At least 3 years of experience in Quality Assurance within Medical Device and/or Pharmaceutical fields.

Responsibilities

• Lead and drive Non‑Conformance investigations related to component failures, finished goods failures, product returns, and other quality events.
• Perform impact assessments, root cause investigations, and define, implement, and verify CAPAs.
• Coordinate cross‑functional investigation teams to ensure timely closure of quality events and compliance with procedures.
• Monitor and report NC metrics and trends, identify opportunities for improvement.
• Lead cross‑functional quality improvement projects to reduce recurring non‑conformances.
• Support planning and response to internal QMS audits and external regulatory inspections.
• Act as SME and assist during audits and inspections.
• Support supplier qualification and supplier quality activities, including SCRs and supplier audits.

Skills

Strong English

French or German

Excellent organization

Effective communication

Teamwork and integrity

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office

Job description

OBJECTIVE AND MAIN TASK OF THE FUNCTION

• Lead and drive Non‑Conformance investigations for components, finished goods, and product returns.
• Perform impact assessments, root cause analyses, and implement effective CAPAs.
• Coordinate cross‑functional teams to ensure timely resolution of quality issues.
• Drive continuous improvement initiatives based on NC trends and quality metrics.
• Support internal and external audits and maintain compliance with the Quality Management System (QMS).
• Contribute to quality reporting, and other QA projects as required.

TASKS

• Lead and drive Non‑Conformance investigations related to component failures, finished goods failures, product returns, and other quality events.
• Perform comprehensive impact assessments, root cause investigations (e.g., 5 Why, Fishbone), and define, implement, and verify the effectiveness of corrective and preventive actions (CAPA).
• Coordinate cross‑functional investigation teams to ensure timely closure of quality events and compliance with internal procedures and regulatory requirements.
• Monitor and report NC metrics and trends, identifying opportunities for continuous improvement and systemic corrective actions.
• Lead and execute cross‑functional quality improvement projects to reduce recurring non‑conformances and improve product and process quality.
• Support the planning, execution, and response to internal Quality Management System (QMS) audits.
• Act as Subject Matter Expert (SME) and/or provide backroom support during external audits and regulatory inspections.
• Support continuous improvement of supplier qualification, supplier management, and incoming material inspection processes.
• Support supplier quality activities, including supplier qualification, performance monitoring, Supplier Corrective Requests (SCRs), supplier investigations, and supplier audits.
• Prepare, review, and maintain quality documentation, investigation reports, and monthly/quarterly quality trend analyses.
• Participate in and moderate Quality Assurance and Corrective Action review meetings.
• Collaborate closely with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and other departments to resolve quality issues and ensure product compliance.
• Perform other quality‑related duties and projects as assigned.

REQUIREMENTS AND SKILLS

• Education: Bachelor’s degree in Engineering or Life Sciences
• Special Knowledge: Strong English skills, both written and spoken
• French and/or German, both written and spoken
• Good IT knowledge in MS office
• Personality: Excellent organization and communication skills
• Flexible and adaptable to change with ability to work under pressure
• Responsible, operate with integrity and teamwork
• Learning attitude and logical approach
• Professional Experience: At least 3 years of experience in Quality Assurance within Medical Device and/or Pharmaceutical fields is required