Beschreibung
Our client is an international company in the medical devices sector, operating in a highly regulated environment (cGMP). In this context, they are seeking a Production Quality Engineer to strengthen their Quality team.
The Quality team is responsible for the operation and maintenance of the elements and tasks of the quality management system (QMS) directly related to the products. Its main role concerns material management: ensuring that the compliant release of all raw materials and in-process materials, as well as finished products, is carried out according to the required schedule to support the company’s overall operations.
Compliant release is defined as the guarantee that materials are safe and effective and pose no risk to patients, end users, or internal manufacturing and control processes. This involves compliance with all regulatory requirements and current good manufacturing practices (cGMP).
Job Purpose
The Production Quality Engineer will be responsible for carrying out production quality activities related to raw materials, intermediate products, and finished products, in accordance with operational objectives, legal and regulatory requirements, and the principles of current good manufacturing practices (cGMP).
The post holder will have knowledge of our processes, products, and equipment and their application, as well as the standards and regulations applicable to the quality management system. This knowledge will enable direct contribution to internal and external audits.
The role is strongly client-oriented: the post holder will regularly collaborate with key contacts from other functions (Supply Chain, Production, Research & Development) to achieve the expected operational results and, if necessary, escalate priority conflicts to their line manager that may arise during planned or unplanned events. This will help, as far as possible, to respect the company’s operational schedules.
Production Quality Engineer
Main Activities and Responsibilities:
- Works within established procedures:
? Release (quality assurance) of incoming goods, intermediate products, and finished products.
? Ensure accurate recording and satisfactory completeness (procedural and regulatory compliance) of all documentation related to operations and completed work.
? Participate in maintaining documentation and computerised systems: incoming delivery registers, manufacturing and control batch records, specifications, standard operating procedures (SOPs) and policies, supplier tracking files, ERP data, and quality management system (QMS) data, among others.
? Provide monthly indicators concerning non-conforming materials and incoming inspection results.
- Preparation and management of:
? Qualification activities for new and existing equipment and systems.
- Has practical knowledge of quality management system concepts and procedures; performs various routine tasks or assignments:
? Evaluation of non-conformities.
? Evaluation of changes (change control).
? Facilitation of quality meetings.
- Continuously develops knowledge of the activity, processes, and clients (internal and external):
? Participate in internal and external audits of clients and regulatory authorities.
? Compile and contribute to quality indicators and their trend analysis related to their activities.
? Identify areas for improvement and contribute to a culture of continuous improvement.
? Demonstrate and embody all key behaviours defined by the company.
? Participate in the internal continuous training and evaluation programme.
- Identifies the problem and all relevant issues in simple situations, evaluates them according to standard procedures, and makes appropriate decisions:
? Ensure that incidents, deviations, and other quality system requirements are recorded, reported, and fully investigated, and that the root cause is established.
? Organise daily work to optimise the use of available time.
- Performs all duties in compliance with applicable GMP, regulatory, and health and safety requirements, demonstrating vigilance towards oneself and others.
- Carry out any other reasonable tasks requested by the company, occasionally, within the quality department.
Profile sought:
Qualifications
- Demonstrated secondary education level (minimum).
- Bachelor’s degree in sciences (pharmacy / biotechnology) or equivalent.
- Relevant professional experience in a GMP environment.
- Experience in a controlled environment according to applicable regulatory standards: ISO 13485, Directive IVDD 98/79/EC, FDA Code of Federal Regulations.
- Good command of main IT tools, especially Microsoft Excel.
- Good communication skills and aptitude for a collaborative approach.
- Proactive approach and explicit attention to detail.
- Good team spirit and effective time management.
- Demonstrated ability to analyse information in a structured manner and write coherent reports.
- Ability to lead a team, with good organisational skills.
- Fluent in English and French.