Key Skills

Job Description

Job Overview 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 Team Leadership & Planning 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 Essential: 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). Desirable: 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

Core Responsibilities

Supervise and plan the daily work of QC Analysts while performing or overseeing chemical, physical, and microbiological testing, raw material release, and batch record data review. Maintain QC equipment qualifications, methods, documentation, and training records, and support investigations, audits, and ongoing compliance with GMP and ISO 13485.

Requirements

Requires an HLO or bachelor's degree in Laboratory Techniques, or equivalent relevant work experience, professional-level spoken and written English, and at least three years of team leadership or supervision experience. Candidates must have hands-on regulated laboratory experience, familiarity with QC testing methods, and experience planning testing workloads; Dutch language skills and Class III medical device experience are desirable.