Quality Engineer

at  Corbion

AT CORBION, WE EXIST TO CHAMPION PRESERVATION IN ALL ITS FORMS, PRESERVING FOOD AND FOOD PRODUCTION, HEALTH, AND OUR PLANET.

The Quality Engineer is responsible for ensuring procedures, systems and processes effectively meet the Quality and Regulatory requirements and Biomaterials business needs. The successful candidate will be a seasoned professional with experience in pharma, medical device or related FDA regulated industry. The individual should have a thorough working knowledge of ISO 9001; ICH Q7; CFR 210/211; CFR 820; ISO 13485 and other applicable regulations. As Quality Engineer you will be the quality lead in Strategic projects involving introduction of new production processes and/or introduction of new products.

Responsibilities:

• Support in maintaining and continuously improving the Quality Management System in compliance with GMP regulations and ISO requirements.
• Provide compliance and quality guidance and training to the Operations, Research and Development and Quality Control departments.
• Interact with internal stakeholders and internal/external customers to ensure Quality and Regulatory requirements for Strategic projects are identified and addressed as part of the project plan.
• Drive the establishment of a proper quality control strategy for new processes and new products by applying quality risk management principles throughout the different phases of Strategic projects.
• Support Commissioning, Qualification and Validation activities including associated documentation for new equipment.
• Improve quality risk management procedures to ensure periodic review and performance reporting.
• Maintain current knowledge of FDA, EMA and other international regulations, guidelines, and standards (such as ICH, USP, Ph. Eur.) applicable to industry. Monitor and identify developments to the legislations and translate these to the Biomaterials business.
• Perform annual product reviews for commercial products.
• Support the QA department with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, Non-Conformance and Complaint handling.

About you:

• Bachelor’s or Master’s degree in Chemistry, Engineering, Life Sciences or other relevant area.
• Minimum 5 years of experience as Quality Engineer in pharmaceutical, medical device or other related industries.
• Experience with Commissioning, Qualification and Validation activities for new production equipment.
• Experience in applying Quality Risk Management principles and tools (ICH Q9, FMEA, HACCP, HAZOP, etc.).
• Working knowledge of ISO 9001, ICH Q7, FDA CFR 210/211, CFR 820, EU GMP, EU MDR, ISO 13485 and other applicable regulations.
• Strong written and verbal communication skills, in English and preferably in Dutch.
• Some exposure to customer audits and/or regulatory agency inspections (e.g. FDA, notified bodies, etc.).
• Proven ability to work cross-functionally to achieve business outcomes.
• Attention to detail, commitment to quality, accuracy, efficiency, and consistency.
• Ability to travel occasionally as determined by business requirements.

• Support in maintaining and continuously improving the Quality Management System in compliance with GMP regulations and ISO requirements.
• Provide compliance and quality guidance and training to the Operations, Research and Development and Quality Control departments.
• Interact with internal stakeholders and internal/external customers to ensure Quality and Regulatory requirements for Strategic projects are identified and addressed as part of the project plan.
• Drive the establishment of a proper quality control strategy for new processes and new products by applying quality risk management principles throughout the different phases of Strategic projects.
• Support Commissioning, Qualification and Validation activities including associated documentation for new equipment.
• Improve quality risk management procedures to ensure periodic review and performance reporting.
• Maintain current knowledge of FDA, EMA and other international regulations, guidelines, and standards (such as ICH, USP, Ph. Eur.) applicable to industry. Monitor and identify developments to the legislations and translate these to the Biomaterials business.
• Perform annual product reviews for commercial products.
• Support the QA department with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, Non-Conformance and Complaint handling