Quality and Regulatory Affairs Manager

15. November 2022

Stellenbeschreibung

Company Description

Lunaphore Technologies is a company born with the vision of accelerating cancer research by making spatial biology mainstream in every research laboratory. We build solutions that simplify technology adoption for discovery and translational research laboratories and empower researchers to develop better-targeted treatments for cancer and other diseases.

Job Description

Reports to: VP of Operations
Ideal Start Date: As soon as possible
Type of Contract: Permanent / CDI

Role Overview

We are looking for a QA/RA manager to lead the team of QA, RA and QC in Lunaphore. The QA/RA manager will be responsible for the QMS of the company as well as Quality company goals. He/She will also ensure that Lunaphore products meet all necessary regulatory requirements. The QA/RA manager will coordinate the QA/RA team, working in close collaboration with the Supply Chain, Manufacturing, and R&D departments. The candidate has experience with mechanical/electronic devices and/or Medical Devices or IVD. The QA/RA manager will report to the VP of Operations.

Responsibilities and duties

  • Maintain the Quality Management System (QMS) of the company in compliance with ISO9001
  • Ensure compliance of Lunaphore products with the applicable regulatory requirements
  • Be responsible for the final product releases for customers, managing the QC team
  • Be responsible of customer complaints
  • Coordinate and manage external audits, internal audits and supplier audits
  • Interact with the R&D Team to ensure compliance of the product development to regulatory and quality requirements
  • Manage contacts with external parties such as notified bodies, competent authorities or consultants
  • Be responsible for the Quality agreements with distributors and suppliers
  • Leads QA/RA team and influences other cross-functional teams
  • Ensure the recruitment, training, evaluations and professional development of the team members
  • Responsible for Quality KPIs
  • Report to VP operations the progress of the team’s work
  • Support the VP operations to plan, administrate and monitor the QA/RA department annual budget

Qualifications

  • A degree in a Life sciences/Engineering related field and/or a certificate in Quality Assurance and Regulatory Affairs
  • 8+ years of experience in QA/RA activities
  • Experience in in in-vitro diagnostic (IVD) and ISO 13485 are a must have
  • Experience in quality control in manufacturing plant or industry following the ISO9001 is a must have
  • Experience in working with suppliers is a strong plus
  • Experience with mechanical devices and/or microfluidic chips and/or chemicals
  • Experience in people management and project management
  • Experience in financial aspects of production is a plus
  • Fluency in English (at least C1), French / German / Italian is a plus

Desired Soft Skills

  • Demonstrated ability to run a high-quality organization, strong organizational skills and experience in root cause analysis
  • You like interacting with people, bringing advice and solutions to them, and demonstrating excellent internal communication skills
  • You have excellent leadership and interpersonal skills to lead a team
  • You have excellent project management skills
  • You are able to manage multiple tasks in an autonomous and efficient way
  • You have the ability to collaborate with others by working in a team, share information with peers and superiors
  • You demonstrate excellent organizational skills and attention to details

Additional Information

What we offer

  • A dynamic company where you can have a real impact
  • An environment where you will be able to grow both professionally and personally
  • Collaborate every day with a young, interactive, and motivated team
  • A diverse and international working environment

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