Injection Molding Process Engineer Job in Belgium

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Injection Molding Process Engineer Job Description

Pauwels Consulting is currently looking for a Injection Molding Process Engineer who will determine and report on the state of compliance of the quality system. For our pharmaceutical partner in Switzerland.


The main responsibilities of the Injection Molding Process Engineer are:
 

• 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

What does Pauwels Consulting require from the Injection Molding Process Engineer:
 

• 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

What can you expect from Pauwels Consulting.

A responsible position in a leading international company.
Personal development opportunity’s through learning on the job and additional external trainings.
You can expect a market oriented compensation, including a wide range of fringe benefits


Please apply with your CV and cover letter by the 'apply' button below
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Injection Molding Process Engineer Summary

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