Overview
Mona Lisa is one of the world's leading manufacturers of copper intrauterine devices, offering hormone-free contraceptive solutions that meet the diverse needs of women globally. As a family-owned company, we pride ourselves on our positive culture built on respect, integrity, transparency, and trust, supported by strong leadership. We are seeking a Quality Assurance Specialist to join our small, close-knit team in Belgium. This role requires an autonomous professional with at least five years of experience in medical devices, pharmaceuticals, or other highly regulated industries who thrives in a hands-on environment. If you are solution-oriented, flexible, and passionate about continuous learning while ensuring the highest quality standards, we want to hear from you.
Key Responsibilities
Document Control & Quality Documentation: Create, update, review, and maintain quality documents (SOPs, protocols, reports, records) in accordance with current regulatory and standard requirements.
Ensure all documentation related to environmental control, sterilization, and manufacturing processes is current, approved, and properly controlled.
Ensure alignment of internal procedures with applicable standards and regulatory requirements.
Non-Conformance (NC): Investigate and document non-conformances related to products, processes, and materials.
Collaborate with cross-functional teams to identify root causes and implement corrective actions.
Ensure timely closure of NC reports and track effectiveness of implemented actions.
CAPA (Corrective and Preventive Actions): Initiate and track CAPA investigations to address quality issues.
Ensure compliance with CAPA procedures and regulatory requirements.
Change Management: Support the evaluation and implementation of change controls related to product design, processes, risk management and documentation.
Work closely with QA, regulatory, and production teams to assess risks and ensure compliance.
Maintain updated records of changes and ensure proper approvals are obtained.
Batch Release Support: Review batch documentation for compliance before release.
Ensure that all quality control checks are completed and approved prior to final product release.
Work closely with manufacturing and quality assurance teams to resolve any issues that may delay batch release.
Production Quality Oversight: Provide QA oversight of production activities to ensure manufacturing processes are performed in accordance with approved procedures, specifications, and validated processes.
Review and approve production records, batch manufacturing records, and device master records (DMR) to ensure completeness, accuracy, and compliance prior to product release.
Inspection of Goods (Incoming, In-Process, and Final): Ensure incoming materials, components, and packaging materials are inspected, tested, and released in accordance with approved specifications and inspection plans.
Oversee in-process and final product inspections to verify conformity to defined acceptance criteria.
Review and approve inspection records, test results, and certificates of conformity.
Manage nonconforming materials, including investigation, documentation, disposition (use as is, rework, reject), and implementation of corrective actions.
Education & Working experience
Minimum 5 - 10 years of experience in a quality-related role within medical devices, pharmaceuticals, or a regulated industry.
Minimum of a bachelor’s degree in Science, Engineering or equivalent technical field is required.
Skills & Knowledge
The ability to manage multiple projects and priorities simultaneously.
Strong attention to detail, problem-solving, and documentation skills.
Ability to work independently and as part of a team.
Strong analytical and problem-solving skills. Knowledge of statistical analysis a plus
Fluent in English language. Knowledge of Dutch is an advantage.
Experience with NC, CAPA, Change Management, and batch release processes
Knowledge of regulatory requirements and standards such as 21CFR820, ISO13485, EU MDR 2017/745, EU MDD 93/42 and MDSAP.
Familiarity with risk management (ISO 14971) and validation processes.
Computer skills: Microsoft Office, High proficiency in Excel, SharePoint, Teams
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