Contractor QA Specialist (m, f, d)

Open Position: Contractor QA Specialist (m, f, d)

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

ASAPProject Duration: 4

monthsAssignment Volume: 0 hour(s)

Location: Lucerne, Switzerland

Responsibilities:

• Independently handling production nonconformities
• Independent handling of production CAPAs
• Handling CC measures in production as part of consulting activities
• Consulting on 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
• Independent handling of process validations / documentation of validation reports

Qualifications:

• Completed technical education (vocational school, university of applied sciences, or equivalent)
• Experience in project management
• Demonstrable experience in the validation and qualification of production equipment, including computer software validation
• Continuing education in 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 a strong communicator
• Experienced in risk-based decision-making