Quality Engineer - Materials Controls

For our customer in Basel/Solothurn we are looking for a project for

Quality Engineers/Materials Controllers

As an experienced SME within the Medical Device or Pharma industry the engineer will be providing consultancy and guidance related to Materials Control (21CFR§820 different subparts as well as ISO 13485). The engineer will conduct remediation activities related to existing processes about materials segration and different logistical procedures within the manufacturing sites, audit sites procedures to the standards and provide recommendations to the sites with regards to compliance. Perform CAPA Verficiation of Effectivieness as necessary.

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 for Medical Device Industry (ISO, FDA, etc.)
- Audit sites' procedures to the standards and report out on finding (both current state and retrospectively)
- Make recommendations to achieve compliance where shortfalls are found
- Provide Audit report as directed
- Perform verifications of effectiveness as necessary
- Be willing and able to travel to other sites in Europe as required
- Thorough understanding of GMP and GCP guidelines

Experience:

- Minimum 4 years quality/compliance experience in the medical device or pharmaceutical industries
- 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 Microsoft Office, MS Visio and/or MS Project are a plus
- Some ERP knowledge (preferable Agile, JD Edwards and SAP)

Are you interested in this position? Then we looking forward to receive your application.