Quality Manager

il y a 1 jour


LouvainlaNeuve, Belgique Dekimo Louvain-la-Neuve Temps plein

DEKIMO EXPERTS Louvain-la-Neuve, part of DEKIMO GROUP, delivers both services and advice in two specialized domains: the development of smart systems and software and the improvement of critical processes. Our consultants are involved throughout the whole software & system lifecycle (from design to homologation and production) and contribute to the strategy or critical missions for our customers in a wide variety of industry sectors (automotive, medical, aerospace ).

Dekimo cares for strong relationships with a large existing customer base and has a focus on nurturing as well customer intimacy as relationship with its consultants.

Dekimo is proud to count on long-lasting relationships with trusted customers and on highly skilled consultants.

**Role**

As the leader of our project quality team, set up and implement the various Medical Device QA activities in the organization, in the context of a specific engineering activities for one of our customers (start-up in the medical device field).

**Objectives of this Role**
- Build upon a QA policy within DEKIMO Louvain-la-Neuve’s organization and comply (with) Medical quality assurance standards (ISO 13485, 62304 )
- Carefully maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions
- Document quality assurance activities with internal reporting and audits
- Develop new standards for production and design, with improvements as needed, and create testing protocols for implementation across all service lines
- Identify training needs and take actions to ensure company-wide compliance
- Pursue continuing education on new solutions, technology, and skills

**Main responsibilities**
- Plan, execute, and oversee inspection and testing of incoming and outgoing product to confirm quality conformance to specifications and quality deliverables
- Assist operations and local quality function in tracking, documenting, and reporting quality levels
- Analyze and investigate product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements
- Develop or update company complaint and inspection procedures to ensure capture and investigation, as well as proper documentation of complaints
- Monitor risk-management procedures, and maintain and analyze problem logs to identify and report recurring issues to management and product development
- Provide training and support to quality assurance team on systems, policies, procedures, and core processes

**Qualifications**
- Bachelor’s/master degree with scientific or technical education
- **Minimum 5 years of working experience in a QA management position**
- Complementary background (medical field) is a plus, knowledge of ISO 13485, ISO 62304 or GMP standards are wished
- Professional certification, such as Six Sigma, Quality Engineer, or Quality Auditor
- Knowledge of quality assurance terminology, methods, and tools
- Analytical, problem-solving, and decision-making skills
- Outstanding ability to communicate
- Demonstrated knowledge of testing best practices, version control practices and defect management practice
- Languages : English AND French

**Skills**

Type d'emploi : CDI

Avantages:

- Assurance groupe
- Assurance hospitalisation
- Carte essence
- Chèques repas
- Éco-chèques
- GSM de fonction
- Ordinateur de fonction
- Voiture de société

Flexible Language Requirement:

- Néerlandais non requis

Programmation:

- Lun-Ven
- Travail de jour

Types de primes et de gratifications:

- 13ème mois
- Pécule de vacances



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