- Jan 15, 2024
Siemens Healthineers has an opening for an experienced Product Quality Assurance Engineer in an ISO 13485 and FDA 21 CFR IVD manufacturing environment, with experience in product and process quality.
Siemens Healthineers has an opening for an experienced Product Quality Assurance Engineer in an ISO 13485 and FDA 21 CFR IVD manufacturing environment, with experience in product and process quality for Medical Devices including new product introduction at our site in Swords, County Dublin.
Now's our time to inspire the future of healthcare together
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
This is a role well suited to an ambitious Engineer, looking for the next challenge in their career as a Quality Engineer
Siemens Healthineers, offers an excellent opportunity to work in a leading manufacturing facility. The successful applicant will be a key member of an expanding Quality team and is expected to lead, guide and mentor colleagues in developing and supporting next generation medical diagnostic analyzers (immunoassay and chemistry).
The applicant must have a proven track record in medical device Quality preferably with complex instrumentation. 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 Engineers 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 Product Quality team, collectively responsible for maintaining and improving quality & compliance in the manufacture and support of our products and services.
You must demonstrate the ability to work collaboratively in a systematic fashion with other cross-functional stakeholders (Engineering, Production and Procurement) creating and ensuring value-streams comply with QMS requirements and production targets.
As a key member of the team, you will be part of a highly innovative production and Quality network working to deliver high Quality product to serve the needs of laboratories of any size - today and tomorrow.
The critical skills we are looking for:
- Proven experience in QMS working in a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling and validation. Has demonstrated strong competencies and leadership in these areas.
- Prominent in 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.
It would be advantageous to have the following experience:
- 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.
- Worked within Quality in a manufacturing environment for complex electro-mechanical equipment.
Required for the success of this role:
- High paced individual who is eager and passionate in developing and delivering quality solutions in close collaboration with key stakeholders
- Leadership skills in Quality 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 diagnostic technologies would be an advantage.
- Minimum of Bachelor's degree in relevant technical discipline (ideally Engineering, Quality or Science)
- Minimum 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.