Quality Control Supervisor

Sinclair; Almere; Presencial; EUR 55 000 - 75 000; Tempo integral

Resumo da oferta

Sinclair is seeking a QC Supervisor in Almere, NL to lead and coordinate a QC Analysts team in a Class III medical device environment. You will oversee chemical, physical, and microbiological testing, ensure on-time batch release support, and maintain QC documentation under GMP/ISO 13485.

This hands-on leadership role requires setting daily plans, training staff, reviewing raw materials, and backing the Quality Manager during absences, audits, and CAPA actions.

Qualificações

• Bachelor's degree in Laboratory Techniques or equivalent.
• Fluent English; professional written and spoken.
• 3+ years leading a team in GMP/ISO 13485 lab or QC.
• Experience planning daily/weekly QC testing.
• Dutch fluency (speaking and writing).
• Hands-on QC testing in regulated environment.
• Experience with QC equipment operation and calibration.

Responsabilidades

• Supervise, coach, and support QC Analysts in daily operations.
• Create and manage daily/weekly QC team planning to meet test turnaround times.
• Train new QC Analysts and maintain competency matrix.
• Act as backup for the Quality Manager during absences.
• Conduct performance conversations and contribute to appraisals.
• Provide QC data and input to CAPA investigations.

Conhecimentos

Team leadership

QC testing

Planning & scheduling

Training

Documentation

GMP/ISO 13485

English proficiency

Dutch language

ERP/QMS familiarity

Equipment calibration

Formação académica

Bachelor's in Laboratory Techniques

Ferramentas

ERP software

QMS

QC equipment

Descrição da oferta de emprego

The QC Supervisor is responsible for the day-to-day coordination and technical oversight of the QC team within a Class III medical device manufacturing environment. This role ensures that all chemical, physical, and microbiological testing is performed accurately and on time, supports the review of raw material intake and batch record testing data, and maintains equipment qualification and QC documentation in line with GMP/ISO 13485 requirements. The QC Supervisor leads, trains, and plans the daily work of QC Analysts, and acts as a key backup for QC-related operational and technical matters, ensuring continuity of QC operations at all times. This is a hands‑on leadership role requiring both strong technical QC expertise and proven team supervision experience.

Job Requirements

• Supervise, coach, and support QC Analysts in daily operations.
• Create and manage daily/weekly QC team planning to ensure test turnaround times are met.
• Train new QC Analysts and maintain team competency matrix.
• Act as backup for the Quality Manager during absences.
• Conduct performance conversations / input into appraisals.

Testing & Technical Execution

• Perform and/or oversee chemical, physical, and microbiological QC testing per approved methods.
• Ensure all QC testing is completed within required timelines to support batch disposition by Quality/QA.
• Perform review and release of incoming raw materials in ERP/QMS (raw material release authority sits with QC).
• Perform QC review of batch record test data (intermediate and finished product) for completeness and accuracy, and forward results to the Quality team for final batch disposition.

Equipment & Method Lifecycle

• Own qualification (IQ/OQ/PQ) and calibration scheduling of QC equipment.
• Support new QC projects, including specification and purchasing of new equipment.
• Ensure method validation/verification status is current and documented.

Quality System & Compliance

• Report non-conformities to the Quality team and initiate Out-of-Specification (OOS) investigations.
• Provide QC data and technical input to Quality team for CAPA investigations.
• Maintain work instructions/SOPs relevant to QC processes, ensuring version control.
• Maintain personal training file and ensure team training records are current.
• Support internal and external audits as QC subject matter expert.
• Ensure GDP (Good Documentation Practice) compliance in all QC records.

Required skills & Responsibility

• HLO / Bachelor's degree in Laboratory Techniques (or equivalent through relevant work experience);
• Fluent in English, both spoken and written, to a professional level;
• Minimum 3 years of experience leading/supervising a team, ideally within a regulated (GMP/ISO 13485) laboratory or QC environment;
• Proven experience with daily/weekly planning of laboratory or QC testing activities, balancing workload against release deadlines and unplanned investigations;
• Hands‑on laboratory experience in a regulated environment;
• Experience with QC test methods (chemical, physical, and/or microbiological).
• Dutch speaker and writer (fluent)
• Hands‑on experience with QC equipment (operation, troubleshooting, and ideally qualification/calibration)
• Experience in a Class III / high‑risk medical device environment specifically