Collins McNicholas

As the Manufacturing Regulatory Compliance Specialist expert, reporting to the Manufacturing Manager, you will participate and be part of a major new function within our clients existing site with the support and resources that you’d expect from a well-established multinational. The Irish Manufacturing facility will have responsibilities for the processing and delivery of all global Hardware and Software orders.

Reporting to the manufacturing manager, this role is responsible for maintaining  Internal quality systems and regulatory compliances needed to manufacture and export telephony equipment and associated peripherals to their customers in key global markets.

Primary Roles and Responsibilities

  • Manages all manufacturing activities related to internal quality systems, management reporting and regulatory compliance required to support shipping of products to key global markets.
  • Ensure the Quality systems and manuals are maintained, employees and managers trained and all internal and external audits are prepared for.
  • Work to maintain the various Regulatory Accreditations (Chinese CQC, European CE & WEEE and US UL) as required to ship into each key market.
  • Gathers data, prepares reports and presents to management reports including Quarterly Quality Review (QQR) and Quarterly Performance Review (QPR).
  • Support’s production as needed building their Telephony Servers using subcomponents supplied by their Original Equipment Manufacturers (OEM) and load software images as required.
  • Work with R&D engineering to support the qualification and regulatory compliance efforts for new products.
  • Work with the manufacturing team to generate Engineering Change Orders as needed to document and update work instructions and ensure that systems and processes are in line with the Internal quality manual.
  • Participate in ‘On Call’ Rota to support the Out of Hours delivery of post sales spares and flexibility required at quarter end to meet revenue targets.

Qualifications/experience required:

  • Diploma or bachelor’s degree preferred, or an equivalent combination of education and experience.
  • 4-6 years of experience in a ‘high tech’ manufacturing assembly environment.
  • Familiarity with ISO and the quality systems used by manufacturing organizations and external International regulatory compliance requirements.
  • Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
  • Experienced in the use of ERP systems (NetSuite would be a distinct advantage) and Competent using office software Word, Excel and PowerPoint.
  • Completes assignments and tasks with limited oversight.
  • Ways to stand out for this role
  • Experience in a ‘hi-tech’ multinational manufacturing environment.

 

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