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Manufacturing Engineer/SME - Solothurn, Switzerland

Eingestellt von Templeton and Partners

Gesuchte Skills: Engineer, Sap

Projektbeschreibung

Manufacturing Engineer/SME - Solothurn, Switzerland

Experience:
- Minimum of 10 years experience as manufacturing engineer in medical device metal industry.
- Compliance experience in the medical device.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO 13485/9001 required.
- Proficient in the use of spreadsheet software (Access/Excel etc.)

Subject Matter Expert (Equip & Facilty Eng Manufacturing):
Duties and Responsibilities:
- With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
- Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively).
- Make recommendations to achieve compliance where shortfalls are found.
- Provide Audit reports as directed.
- Consultancy and guidance of all employees and manager regarding manufacturing and facility and operational practices.
- Training of all involved employees along the manufacturing and facility process.
- Consultancy and guidance of all employees regarding PFMEA and Risk Management
- Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices.
- Consultancy and guidance of all employees regarding maintenance
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
- Be able to manage effectively multiple priorities and tasks.
- Be willing and able to travel domestically to other Legacy client EU sites as required.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Fluently German/English spoken and written
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.).
- Good communication skill
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
- Team player

Projektdetails

  • Einsatzort:

    Solothurn, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    7 months+

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    SAP Entwicklung, Ingenieurwesen/Technik

  • Skills:

    engineer, sap

Templeton and Partners