Acceptance Procedures Subject Matter Expert

For a project in Solothurn, we are looking for a SME - ACCEPTANCE PROCEDURES

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.
- Make recommendations to achieve compliance where shortfalls are found.
- Provide Audit reports as directed.
- Perform analyze and define Inspection Plan as necessary.
- Generate Inspection Plan as necessary.
- Background on statistics.
- Background on validation.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Generate DCRs/DCOs that these achieve the regulatory and the business requests.
- Fluent German spoken and written; English is an advantage
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
- Good communication skill.
- Know 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.
- Travel required form site to site.
- Be able to manage effectively multiple priorities and tasks.

Experience:
- Minimum of 4 years quality planning
- Compliance experience in the medical device.
- 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 spread sheet software (Access/Excel etc.)
- Engineering, Manufacturing Degree BSc

Are you interested in this position? We are looking forward to receive your application.

Many thanks.