QA Manager

at  Nipro Europe Group Companies

WHAT YOU’LL NEED

• Strong experience in QMS, audits, complaints and post market surveillance
• Strong experience with ISO 13485 and MDR
• People management experience
• Msc in science is preferable (such as bioengineering, biomedical, biochemistry,…)
• Strong communication skills
• Entrepreneurship mindset
• Corporate/HQ experience is a plus
• Excellent English written and spoken. Any other language is a plus.

ABOUT THE ROLE

The Quality Manager establishes and maintains a robust Quality Management System (QMS) compliant with ISO 13485:2016 and other relevant regulatory and customer requirements.
The Quality Manager drives the culture of quality across Nipro Medical EMEA (NME), in alignment with the strategy and supporting the business objectives.
The team consists of 3 people.

WHAT YOU’LL DO

Quality Management System

• Responsible of the day to day quality management system (QMS) processes and ensuring continuous improvement with the appropriate management involvement with the applicable standard and regulations (ISO 13485, MDR,…)
• Develop and implement QMS and quality culture at NME branches
• Be the Management Representative of NME (Back up)
• Be the Person, Responsible for Regulatory Compliance as a backup. (PRRC)

Internal and external audits

• Build internal audit plan and ensure its execution. Lead internal and external audit
• Ensure CAPA documentation and follow up

Complaints and product return management

• Overall responsible of the complaints handling process and strive to continuously improve processes and procedures in order to reduce goods returned and improve stock for resale efficiencies.
• Provide trend analyses to RAQA management.

Post Market Surveillance

• Schedule and coordinate for proactive and vigilance activities according to schedule; gathering inputs from cross-functional stakeholders and escalating at risk findings to RAQA management.
• Ensure timely reporting, accurate and comprehensive medical device reporting, and follow up, timely and comprehensive response to competent authority enquiries, and another global government agency request, in closed collaboration with the product legal manufacturers.
• Is accountable for incident reporting to the competent authorities (materiovigilance contact person, NME territories)