Injection Molding Process Engineer Job in Belgium

Pauwels Consulting staffs, manages and executes projects and we recruit top experts for leading companies in Engineering, Pharma and IT. How may we help you?

Injection Molding Process Engineer Job Description

• 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 analyses and define Inspection Plans as necessary.
• Generate Inspection Plan as necessary.

Injection Molding Process Engineer Job Requirements

• Minimum of 4 years quality planning.
• Compliance experience in 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.
• Background in statistics.
• Background in validation.
• Be willing and able to travel domestically to other Legacy 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 (you will be trained on the Company System).
• Fluent in German and 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 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, customer oriented.
• Team player.
• Travel required between the site's
• Be able to manage effectively multiple priorities and tasks.

Injection Molding Process Engineer Application Information

Do you want to apply for this position? Please send us your cv and cover letter below. Do you have additional questions? Please mail us at [email protected] or give us a call at 0032 9-324 70 80.

Injection Molding Process Engineer Summary

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