NPI Quality Engineer - Med Device

Competitive
Permanent
Cork
16 Mar 2020
BBBH756304

EXCELLENT Permanent NPI Quality Engineering Opportunity

I am working with a global medical device company who deliver innovative, value-added solutions improving quality of life for patients worldwide. They are a recognised leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand) and lower extremities (foot and ankle). Their site based in Cork are looking for an NPI Quality Engineer to join their team on a permanent basis.

This company are known for their internal opportunities and this role has come about as there has been a promotion within the team.

There are a number of live NPI projects in process on site and a number more to come live in 2020 so this is a great time to join the business. The successful individual will be working closely with remote teams so communication and teamwork will be key in this role. You do not need to have prior NPI experience for this role as the team are happy to provide training but having some experience would be beneficial. Previous experience working in a highly regulated environment (Med-device or Pharma) is a prerequisite as well as at least 3 years' experience within a quality role

The key responsibilities will be highlighted below:

KEY RESPONSIBILITIES:

  • Represent Quality Engineering through all product design and development phases to help ensure product manufacturability, reliability and cost effectiveness.
  • Define validation strategy according to existing procedures, standards, specifications, equipment, manufacturing process and existing validated products.
  • Create documentation associated with Quality Engineering activities including quality plans, validation protocols and reports and update Quality System procedures. Create and provide validation documentation according standards and regulation for product registration.
  • Monitor and report on progress of the project to all stakeholders, identifying risks and steps for mitigation.
  • Ensure adherence to regulatory requirements, namely ISO and FDA.
  • Interface with Suppliers for new processes, quality issues and process improvements.
  • Support the investigation and documentation of Customer complaints, CAPAs, and NCEs.

If you would like to learn more about this opportunity or would like to be considered for the role then click the 'apply now' button and I will be in touch. Alternatively you can reach out to Kellie on 021 2300 300

Some other quality opportunities in Cork:

  • Quality Specialist - Pharma - Permanent
  • Senior Quality Engineer - Med Device - Permanent
  • Senior Quality Manager - Med Device - Permanent
  • Reg Compliance Coordinator - Med Device - Permanent
  • Quality Lead - Essential Oils - Permanent

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Kellie O'Donovan's picture
Consultant | Engineering Recruitment - Quality & Validation
Cork 353 (0) 21 2300300 | kodonovan@morganmckinley.com