QA Lead: Non-Conformance & CAPA Expert

STAAR Surgical Company; Indiana (PA); Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Strong English

French or German

Excellent organization

Effective communication

Teamwork and integrity

Ausbildung

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office

Jobbeschreibung

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.