Metrology Project Manager

BVI Medical; Luik; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

BVI Medical is seeking a Metrology Project Manager to lead metrology, validation, and quality activities across development, industrialization and manufacturing. You will drive reliable measurement systems and validation processes to ensure product quality and regulatory compliance.

Collaborate with R&D, Industrialization, Production and Quality teams to validate new products and equipment, and oversee IQ/OQ/PQ/CSV activities.

Qualifications

• Experience in metrology, validation, quality engineering in a regulated manufacturing environment.
• Strong knowledge of IQ/OQ/PQ and computerized system validation (CSV).
• Experience with measurement systems, calibration principles, and MSA (Measurement System Analysis).
• Knowledge of quality systems and applicable regulatory standards.
• Strong project management, planning, and organizational skills with ability to coordinate multiple activities and stakeholders.
• Excellent communication and collaboration skills across cross-functional teams.
• Fluent English and French.

Responsabilités

• Define, select and implement measurement resources to support manufacturing of products.
• Lead validation of test methods, production equipment, manufacturing processes, and computerized systems (IQ/OQ/PQ/CSV).
• Collaborate with R&D, Industrialization, Quality Assurance, Regulatory Affairs and Production to validate new products, equipment, methods and software.
• Develop control specifications, sampling instructions and inspection methods for materials and components.
• Prepare validation protocols, reports and documentation ensuring effective QC/production implementation.
• Coordinate technical assessments of contract laboratories for product and process verification/validation.
• Contribute to MSA studies to evaluate measurement system accuracy, repeatability, and process capability.

Connaissances

Project management

Quality engineering

Cross-functional collaboration

Communication

Bilingual EN/FR

Outils

IQ/OQ/PQ validation

CSV validation

Description du poste

Purpose

We are seeking a Metrology Project Manager to lead metrology and validation activities supporting new product development, industrialization, and manufacturing operations. This role is responsible for ensuring test methods, measurement systems, production equipment, manufacturing processes, and computerized systems are validated in compliance with applicable quality and regulatory requirements. Working closely with R&D, Industrialization, Production, Quality, and external partners, the Metrology Project Manager drives the implementation of reliable measurement systems and validation processes that support product quality, operational performance, and successful product commercialization.

Key Responsibilities

Metrology

• Define, select, and implement measurement and control resources to support the manufacturing of BVI products.
• Define calibration methods, measurement procedures, and sampling instructions for measurement equipment.
• Define specifications for measurement equipment acquisition projects and manage implementation through production release.

Validation & Quality Control

• Lead or coordinate the validation of test methods, production equipment, manufacturing processes, and computerized systems (IQ/OQ/PQ/CSV).
• Collaborate with R&D, Industrialization, Quality Assurance, Regulatory Affairs, and Production teams to validate new products, equipment, methods, and software.
• Define, validate, and transfer quality control methods to the Quality Control and Production teams.
• Develop control specifications, sampling instructions, and inspection methods for raw materials and components.
• Prepare validation protocols, reports, and supporting documentation, ensuring effective implementation within Quality Control and Production.
• Participate in technical assessments of contract laboratories supporting product and process verification and validation.
• Contribute to Measurement System Analysis (MSA) studies to evaluate measurement system accuracy, repeatability, reproducibility, and process capability.

R&D & Industrialization

• Collaborate with R&D and Industrialization teams to anticipate metrology and validation requirements for new products and manufacturing processes.
• Support the development and execution of product verification and validation activities.
• Participate in cross-functional project meetings to ensure alignment throughout product development.

Quality System

• Report non-conformities and quality-related issues to the relevant managers and Quality Assurance.
• Escalate any events that could impact product quality, regulatory compliance, or the successful execution of assigned activities.

Qualification

• Experience in metrology, validation, quality engineering, or a related role within a regulated manufacturing environment.
• Strong knowledge of validation methodologies, including IQ/OQ/PQ and computerized system validation (CSV).
• Experience with measurement systems, calibration principles, and statistical analysis (e.g., MSA).
• Knowledge of quality systems and applicable regulatory standards.
• Strong project management, planning, and organizational skills, with the ability to coordinate multiple activities and stakeholders.
• Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams.
• Strong attention to detail, a quality-focused mindset, and the ability to work independently while managing competing priorities.
• Fluent English & French.

Company

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept - taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com