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Quality Professional

Job Description

Product Quality Professional

Permanent Role

(Science or Engineering background)

Siemens Healthineers has an opening for an experienced Product Quality Professional in an ISO 13485 and FDA 21 CFR Part 820 IVD manufacturing environment, with experience in product and process quality including new product introduction at our site in Swords, County Dublin. This is an excellent opportunity to work in a leading manufacturing facility. The quality function works cross-functionally with Engineering, Production and Procurement to cover a wide area of responsibilities such as CAPA, Non-Conformances, Risk Management, Deviations, Inspections and Regulatory audits, Complaint Handling, Validation and Product Release.

The Swords site is currently involved in new product introductions, so this is an exciting time to join an existing team of Quality professionals to help develop the future processes of the Swords manufacturing site.

The successful applicant shall report directly to the Product QA manager and is a member of the site Quality team, collectively responsible for maintaining and improving quality & compliance in the manufacture and support of our products and services.

Responsibilities:

Product & Process Quality:

  • Work collaboratively with cross-functional stakeholders (Engineering, Production and Procurement) creating and ensuring value-streams comply with QMS requirements and production targets.
  • Experienced in QMS covering a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing and process deviations, non-conformance handling and validation. Has demonstrated strong competencies and leadership in these areas.
  • Contributor to change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, CAPA, continuous improvement changes, and post-production (proactive surveillance). This will require a systems mindset incorporating a cross technology understanding, in addition to a core appreciation of risk and regulatory requirements.
  • Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control.
  • As a member of the site Quality team, you will focus on and be responsible for process design improvements and updating quality system procedures to achieve both fully compliant and lean processes.
  • Using lean tools, own and lead quality projects that deliver quality, cost, and process improvements.
  • Assess manufacturing's capability to meet quality requirements based on data analysis and internal audit. As a follow-on activity create concise reports that enable project teams to implement improvements and corrective actions.
  • Experienced in the use of statistical analysis to support technical report writing to meet Quality Systems and regulatory standards of excellence.

Qualifications/Skills/Experience for this role:

  • Minimum of Bachelor’s degree in a relevant technical discipline (ideally Quality, Engineering or Science)
  • At least 5 years relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management incl. writing and / or reviewing Quality related procedures, plans and reports.
  • Strong leadership skills and ability to influence cross-functional teams to drive workscope to completion.
  • Self-starter, bias for action with ability to follow assignment through to completion. Good organization skills.
  • Cross technology and cross discipline collaboration skills.
  • Aptitude for systems level thinking, including development of standard operating procedures.
  • Ability to write structured, concise, unambiguous technical English with high attention to detail.
  • Core understanding of statistical analysis and design of experiment experience. Familiar with statistical software packages e.g., Minitab.
  • Computer literacy (including MS Word/ Excel/ PowerPoint/ MS Project) and Interface to Product Lifecycle tools such as SAP, Teamcenter or other.
  • Presentation skills whereby complex messages can be presented to an auditor/ inspector in a succinct manner i.e., ability to present and to sell convincingly.
  • Understanding of Immunology, Biochemistry & Hematology diagnostic technologies would be an advantage.

About Siemens Healthineers in Swords, County Dublin, Ireland.

The Siemens Healthcare Diagnostics Manufacturing facility is based in Swords, Co. Dublin and is a state-of-the-art production facility manufacturing and supporting complex medical diagnostics analyzers for a worldwide market.

Siemens is a global powerhouse of innovation. The Dublin site delivers innovation with In-Vitro Diagnostic Medical Devices, operating in the healthcare sector. Innovations provide answers to the toughest questions of our time – how to improve healthcare for our citizens, how to protect the environment and the climate, and how to operate sustainably within industrial manufacturing. The company has over 400,000 employees worldwide working to develop answers to the toughest of questions affecting the world today, such as:

How can disease be detected before it strikes?

How can you power a planet hungry for energy without damaging it?

How can you manufacture customized products for our Customers?

How do we maintain compliance in a complex global environment?

Our people are driven by the challenge to deliver leading edge solutions to answer these questions and innovation is the springboard for the answers we provide. We are constantly seeking intensely committed, highly qualified people to transform inventions into successful products and solutions that are compliant to satisfy our Customers.

Siemens Healthineers employs more than 330 people in Swords, so if you're thinking of joining us, you’re in very good company!


If you want to join apply online - https://jobs.siemens.com/healthineers/jobs?location=ireland&stretch=0&stretchUnit=MILES&page=1

Any issues: eve.kinderyte.ext@siemens-healthineers.com


Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Limited

Experience Level: Experienced Professional

Full / Part time: Full-time

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