Contractor QA Specialist (m, f, d)

Project Opening: Contractor QA Specialist (m, f, d)

Industry: Medical Technology
Skills: QA, Quality Assurance, ISO 13485, Capa, NC

Project start: ASAP

Project duration: 4 months

Assignment volume: 0 hour(s)

Location: Lucerne, Switzerland

Responsibilities:

• • Independently handling production deviations

  • Independently handling production CAPAs

  • Handling CC measures in production as part of consulting activities

  • Providing consulting support for the revision of production work instructions

  • Providing consulting support for the preparation, execution, and follow-up of external audits

  • Independently handling internal CAPAs, SOPs, and nonconformities within the internal quality system

  • Independently handling process validations / compiling validation reports

Qualifications:

• Completed technical education (vocational school, university of applied sciences, or equivalent)
• Experience in project management
• Demonstrable experience in validation and quality assurancefiof production facilities, including computer software validation
• Continuing education in the field of quality management
• In-depth knowledge of quality assurance/GMP
• Proficiency with SAP and quality tools (e.g., FMEA, SPC, etc.)
• Good written and spoken English skills
• Customer- and solution-oriented, quality-conscious, and communicative
• Experienced in risk-based decision-makingfidecision-making