Quality Assurance Manager

Loparex B.V.; Apeldoorn; Presencial; EUR 61.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Room for initiative

Growth opportunities

International environment

Dynamic team culture

Descripción de la vacante

Loparex B.V. in Apeldoorn, Netherlands, seeks a Quality Assurance Manager to own and enhance the site quality system (ISO 9001 and GMP) and ensure compliant product release. You report to the Global Quality Director and manage a team of QA and QC staff on site.

You will lead, coach and develop the team, drive CAPAs, audits, and continuous improvement initiatives, and partner with production to sustain operational excellence in a global leader. Fluency in Dutch and English is required.

Formación

• Bachelor's level of thinking; degree in chemistry, chemical engineering or equivalent is a plus.
• At least 5 years of experience in a managerial role within a production-oriented environment.
• Knowledge of statistical techniques, including SPC, Lean Manufacturing and Six Sigma.
• Fluency in Dutch and English, both spoken and written, is required.
• Experience in quality roles within regulated industries (pharma/medical devices) is a plus.

Responsabilidades

• Leadership: Lead the Quality Assurance and Quality Control team and drive the execution and improvement of results.
• Eliminating quality losses: Develop and execute master plans to address quality losses and build capability; evaluate and improve inspection/testing effectiveness.
• Non-conformities: Identify and isolate non-conforming products, determine root causes and recommend improvements.
• Release & inspection: Oversee inspection and testing of materials and products, with final responsibility for product release.
• Process ownership: Manage QMS, audits, CAPAs, deviations, risk management and releases; act as process owner for customer complaints and quality-related meetings.
• Coaching: Coach on root cause problem solving for chronic quality issues and develop Continuous Improvement and Lean skills.
• Health checks & training: Conduct quality health checks, witness audits, identify gaps and coordinate training plans.
• Compliance: Ensure work follows procedures and safety/health/environment/quality standards.

Conocimientos

Leadership

QA Management

ISO 9001

GMP

Lean/Six Sigma

Statistical methods

Dutch & English

Educación

Bachelor's degree in chemistry/related

Descripción del empleo

As Quality Assurance Manager, you are ultimately responsible for developing, implementing and maintaining the quality management system at Loparex Apeldoorn, in accordance with ISO 9001 and GMP and, where applicable, other customer-specific quality standards. You are the system owner of all quality-related processes on site, you report to the Global Quality Director, and you are a member of the local management team.

You directly manage a team of approximately 5 QA employees, indirectly manage 4 QC employees, and hold final responsibility for the release of manufactured product. You build capability within your team and ensure that Apeldoorn's quality program remains demonstrably healthy.

Key responsibilities

• Leadership: Lead the Quality Assurance and Quality Control team and drive the execution and improvement of results.
• Eliminating quality losses: Develop and execute master plans to address quality losses and build capability; evaluate and improve the effectiveness of inspection and testing procedures.
• Non-conformities: Identify and isolate non-conforming products, determine root causes and recommend improvements.
• Release & inspection: Oversee the inspection and testing of incoming raw materials, semi-finished and finished products, with final responsibility for product release.
• Process ownership: Manage quality systems such as document control (QMS), internal and external audits, CAPAs, deviations, risk management and releases; act as process owner of the customer complaints system and of quality-related meetings.
• Coaching: Coach on root cause problem solving for chronic quality issues and develop Continuous Improvement and Lean skills across the organization.
• Health checks & training: Conduct regular quality health checks and/or witness audits. Identify gaps and implement appropriate measures; review and coordinate training plans.
• Compliance: Ensure work is carried out according to established procedures and to safety, health, environmental, quality and housekeeping standards.

What do you bring?

• Bachelor's level of thinking and working (HBO/HBO+); a bachelor's degree in chemistry, chemical engineering or equivalent experience is a plus.
• At least 5 years of experience in a managerial role within a production-oriented organization.
• Knowledge of statistical techniques, including SPC, Lean Manufacturing and Six Sigma.
• Knowledge of and expertise in ISO standards and GMP guidelines.
• Strong persuasiveness and perseverance.
• Good communication skills to discuss quality issues with external and internal customers.
• Fluency in Dutch and English, both spoken and written, is required.
• A valid permit to work in the Netherlands.
• Experience in quality roles within the pharmaceutical, medical device or another highly regulated industry is a plus.
• A salary between €5,500 and €8,500 gross per month, based on 36 hours per week.
• Plenty of room for initiative and growth.
• An international environment with a down-to-earth culture.
• The chance to join a dynamic, innovative team working together to build operational excellence at a global leader in its market.