Product Quality Engineer
Product Quality Engineer
(Science or Engineering background)
Siemens Healthineers has an opening for a Product Quality Engineer 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, Deviations, Inspections and Regulatory audits, Complaint Handling, Validation, Risk, Product Release.
The Dublin site is currently involved in two 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 Dublin manufacturing site.
The successful applicant shall report directly to the QA manager and is a member of the site QA team collectively responsible for maintaining and improving quality & compliance in the manufacture and support of our products and services.
Product & Process Quality
1. Work collaboratively with cross functional stakeholders (engineering, production and procurement) creating and ensuring value-streams comply with QMS requirements and production targets.
2. Experienced in QMS covering a broad range of activities including process change, risk assessment, CAPA, complaint handling, non-conformances, validation. Has demonstrated strong competencies and leadership in these areas.
3. 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.
4. Using lean tools, own and lead quality projects that deliver quality, cost and process improvements
5. Experienced in the use of statistical analysis to support technical report writing to meet technical and regulatory standards of excellence. Examples include Gauge R&R, Capability Analysis, sample size justification to support design changes, verifications, validations and deviations.
Design transfer supporting New Product Introduction
1. Responsible for ensuring all design transfer documentation and manufacturing processes are traceable and documented to a standard
that meets GMP and the Design Transfer, Regulatory and Quality Plan requirements. Ensuring all such documentation is audit ready.
2. Identify potential weaknesses in the internal quality /control system and play a lead role developing and implementing the solutions on corrective action.
3. 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.
4. Support the process of generating pFMEA and work instruction documentation for internal manufacturing processes. Support creation of
design transfer plans and own responsibility for reviewing these plans and reports ensuring each meets regulatory and technical standards
guaranteeing new equipment/process is fit for purpose and commissioning records are correctly documented.
5. Support the management of the temporary manufacturing deviation process (TMD) by tracking the status of open and closed deviations.
6. Act as key liaison and knowledge transfer champion among Quality assurance, Manufacturing engineering, R&D, Document control in order achieve overall compliance.
Qualifications/Skills/Experience for this role:
· Minimum of Bachelor’s degree in relevant technical discipline (ideally Quality, Engineering or Science)
· Approximately 5 years relevant experience in a regulated environment with a core appreciation of FDA regulations.
· 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 Biochemistry, Immunology, Hematology diagnostic technologies would be an advantage.
Location(s): Swords Co Dublin