Talent.com
Deze vacature is niet beschikbaar in je land.
Quality Assurance Manager

Quality Assurance Manager

MAN & SCIENCELuik, Luik, Belgium
24 dagen geleden
Functieomschrijving

Quality Assurance (QA) Manager

Location : Liège

Reports to : QARA Director

Department : Quality Assurance & Regulatory Affairs (QARA)

About Man & Science

Man & Science is an innovative medical technology company developing cutting-edge neurostimulation solutions for severe headache disorders. Our focus is on injectable neurostimulators and an X-ray-free navigation system . Operating in a highly regulated environment, we ensure compliance with stringent medical device standards, including ISO 13485 .

Role Overview

We are looking for a Quality Assurance (QA) Manager with experience in ISO 13485 to support our medical device development and supplier quality management . The role involves maintaining our Quality Management System (QMS) , managing supplier compliance, and supporting product development quality activities.

Experience in ISO 62304 (medical device software) and biocompatibility (ISO 10993) is a plus but not mandatory . This position is an excellent opportunity for someone with a few years of experience in medical device QA who is eager to grow in a dynamic and innovative company.

Key Responsibilities

Quality Management System (QMS) – ISO 13485

  • Maintain and improve the ISO 13485-compliant QMS , ensuring compliance with EU MDR and FDA requirements .
  • Support internal and external audits , including notified bodies and supplier audits .
  • Assist in document control, training records, and change management processes .
  • Support risk management activities ( ISO 14971 ) related to product development and manufacturing.
  • Ensure traceability and quality documentation throughout product lifecycle stages.

Supplier Quality Management

  • Work closely with external suppliers and contract manufacturers to ensure compliance with ISO 13485 requirements.
  • Support supplier qualification, audits, and performance monitoring .
  • Assist in managing non-conformances, CAPA (Corrective and Preventive Actions), and supplier quality issues .
  • Collaborate with engineering teams on supplier validation and process controls .

    • Software & Biocompatibility Quality Support (Preferred but Not Mandatory)

  • Support software development teams in aligning with ISO 62304 for medical device software (preferred).
  • Assist in biocompatibility testing and compliance with ISO 10993 (preferred).
  • Work with R&D to ensure proper documentation and verification of software and biocompatibility processes.

    • Continuous Improvement & Compliance

  • Assist in CAPA investigations and root cause analysis .
  • Participate in quality training programs for internal teams and suppliers.
  • Monitor quality KPIs and contribute to continuous improvement initiatives.

    • Qualifications & Experience

  • Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field.
  • 2-5 years of experience in medical device quality assurance .
  • Experience with ISO 13485 QMS implementation and maintenance .
  • Knowledge of ISO 14971 (risk management) and supplier quality management .
  • Familiarity with ISO 62304 (medical device software) and ISO 10993 (biocompatibility) is preferred but not mandatory .
  • Understanding of EU MDR 2017 / 745 and FDA 21 CFR 820 is a plus.
  • Strong organizational and communication skills, with attention to detail.
  • Ability to work collaboratively with engineering, regulatory, and supplier teams .

    • Why Join Us?

  • Be part of a pioneering team developing groundbreaking neurostimulation technologies .
  • Work in a fast-paced, collaborative environment with opportunities for career growth .
  • Competitive salary and benefits package.

    • If you are passionate about quality in medical devices and eager to grow in a dynamic startup environment , we invite you to apply!

    J-18808-Ljbffr