Localisation : Montpellier

Niveau d’expérience : 2-5 ans

Disponibilité : 1 mois

Type de contrat : CDI

Présentation de la société :

KLANIK was designed based on a strong set of values focused on client impact and talent development. KLANIK is more than just another consulting company, it’s a mindset, a disruptive model focused on our talents and opened to collaboration in order to spark creativity among our people.

KLANIK, a global engineering & technology consulting company provides support for its clients’ development strategies around innovation, R&D and IT systems. In a fast paced changing environment, KLANIK acts as a business partner with its clients, based on a comprehensive expertise and the technical capabilities of our top engineers.

At KLANIK, we are passionate about making measurable impacts in everything we do and we believe that our people make us different. Our unique culture and approach of our talents delivering enduring results is built on a consistent approach to develop our people through strong processes and programs: a role playing program, a unique development framework, a tailor made training university and a business incubator.

At KLANIK, you’ll be part of a spirited team where you’ll have options to grow your talent. Join us!

Descriptif du poste :

The Supplier Quality Engineer is responsible for ensuring that all steps are taken to provide the highest quality products to customers :

Suporting the overall Supplier Quality Management.

Providing supplier qualifications, material qualification, material issue resolution, driving supplier corrective actions, and maintain the approved manufacturer list.

Performing Audits Suppliers per compliance with regulatory and corporate requirements.

Participating in new product development and process improvement teams and formulates quality assurance policies and procedures dealing with Suppliers.

Missions :

  • Manages and monitors implementation and effectiveness of corrective actions related to NCR findings.
  • Assists suppliers in developing strategies for corrective action and preventive action.
  • Identifies risks to products and processes that trace to deficient quality systems, uncontrolled critical parameters, changing regulatory requirements, and changing technical requirements.
  • Collects and analyzes quality metrics from various quality systems and develops reports as needed for SRB review. Provides recommendations based on trends.
  • Collaborates with Sourcing to track ongoing supplier quality performance and work with suppliers on quality issues.
  • Approve supplier selection through robust qualification processes.
  • Approve First Article Inspection (desktop or at supplier facility)
  • Develop positive relationships and work closely with Global Supplier Management to manage and implement supplier changes, New Product Introductions.
  • Lead and assist project teams within the organization on supplier quality related issues.
  • Member of Material Review Board
  • Member of Supplier Review Board

Profil :

Position requires a sound technical background (university degree, technical degree or equivalent of technical nature)

Ability to read and interpret drawings

Experience in manufacturing industry (preferably medical devices or pharma) and in a quality organization.

Broad knowledge of regulatory requirements (FDA / ISO / GMP …).

Experience in interpreting and applying regulations and standards, auditing to these standards and prossess good oral and written communications abilities.

Understanding of all engineering fields and internal processes to be audited.

Good problem-solving ability and analytical skills, strong sense of initiative, follow-through and attention to detail.

Excellent interpersonal skills /intercultural impact

Familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel, SAP and MS Project etc..

Good report, business correspondence & procedure-writing skills

Ability to be capa task owner

Knowledge of production and business processes

Details and in depth analysis

Bilingual English/French

Référence de l'annonce : SQE_MZI_006