Description
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 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.
