Quality Assurance Specialist/Engineer

Job Role:

• The Biomaterials Business Unit develops, produces and sells monomers and degradable polymers as raw materials for the medical and pharmaceutical industry. 
• Our products are used, among other things, in the production of medical devices and controlled release medicines. 
• The products are developed and produced to customer specifications in our factories in Gorinchem, The Netherlands and Tucker, GA, USA. 
• This requires very intensive contact with the customer. The application area and the specific market require a very high level of quality and service.
• The Biomaterials Quality Assurance department ensures that raw materials, production process, packaging, storage, transport and service continuously meet and exceed these high standards. 
• This makes sure that our customers receive the consistent high quality product from our client that they have become accustomed to.

Responsibilities:

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.

• 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.
• Coordinate Quality and Regulatory Affairs relating to Drug Master Files (DMF) and Device Master Files (MAF) ensuring filings meet requirements of Regulatory Agencies and business needs. 
• 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.

Requirements:

• Bachelor’s or Master's degree in Chemistry, Engineering, Life Sciences or other relevant area.
• Minimum 2 years of experience as a Quality Engineer in pharmaceutical, medical device or other related industries.
• Experience in maintaining Regulatory filings current and responding to requests from Regulatory Authorities.
• Experience with Commissioning, Qualification and Validation activities for new production equipment.
• Experience in applying Quality Risk Management principles and tools (ICH Q9, HACCP, FMEA, HAZOP, etc.).
• Working knowledge of ISO 9001, ICH Q7, FDA CFR 210/211, CFR 820, 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.