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Injection Molding Process Engineer (Subject Matter Expert)

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Engineer, Sap

Projektbeschreibung

For our customer in Solothurn we are looking for a project ASAP for an Injection Moulding Process Engineer (Subject Matter Expert)

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.
- Perform analysis and define Inspection Plan as necessary.
- Generate Inspection Plan as necessary.
- Background in statistics.
- Background in validation.
- Be willing and able to travel domestically to other EU company sites as required.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Generate DCRs/DCOs that achieve the regulatory and business requests (successful candidates will be trained on the company system).
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
- Good communication skills.
- 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 and customer oriented.
- Team player.
- Travel required form site to site.
- Be able to effectively manage multiple priorities and tasks.

Technical Requirements:

- Minimum of 4 years quality planning
- Compliance experience in the medical device field.
- Prior experience in medical device/pharmaceutical remediation preferred.
- 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.).
- Fluency in German is a MUST, English-fluent.

Are you interested in this position? Then we look forward to receiving your application.

Projektdetails

  • Einsatzort:

    Solothurn, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    29.11.2013

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    SAP Entwicklung, Ingenieurwesen/Technik

  • Skills:

    engineer, sap

Harvey Nash IT Recruitment Switzerland