Beschreibung
Heat Treatment Process Engineer
3-6 month contract
CHF
Solothurn, Switzerland
Our client is seeking a professional Heat Treatment Process Engineer to join their team on site in Switzerland. As the Heat Treatment professional you will be responsible for adding an oversight from the Core Team Leads to determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
Main Responsibilities:
- 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 analyze and define Inspection Plan as necessary.
- Generate Inspection Plan as necessary.
- Background on statistics.
- Background on validation.
- Be willing and able to travel domestically to other EU sites as required.
- 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 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.
- 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 required.
- Proficient in the use of spreadsheet software (Access/Excel etc.)
German: Fluent
English: Fluent
Please send your CV or call