Responsible for maintaining and improving quality & compliance in the manufacture and support of our products and services
Quality Engineer: Medical Devices: North Dublin
The opening is 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 and new product introduction. 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.
- Work collaboratively with cross functional stakeholders (engineering, production and procurement) 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, complaint handling, non-conformances, product labelling. Has demonstrated strong competencies and leadership in these areas.
- As a member of the site Quality team you will focus on and be responsible for process design improvements and updating quality system procedures in order to achieve both fully compliant and lean processes.
- Using lean tools, own and lead quality projects that deliver quality, cost and process improvements
- Experienced in working in a production environment to support root cause activity, develop compliant solutions and support ongoing continuous improvement.
- Support the management of the temporary manufacturing deviation process (TMD) by tracking the status of open and closed deviations.
- Responsible for reviewing validation plans and reports ensuring these meet regulatory and technical standards guaranteeing new equipment/process is fit for purpose and commissioning records are correctly documented.
Qualifications and Experience:
- Minimum of Bachelor's degree in relevant technical discipline (ideally Quality, Engineering or Science)
- Approx 3 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
- Understanding of statistical analysis and design of experiment experience would be an advantage.
- Computer literacy (including MS Word/ Excel/ Powerpoint/ MS Project) and Interface to Product Lifecycle tools such as SAP, Teamcenter
- Understanding of Biochemistry, Immunology, Hematology diagnostic technologies would be an advantage.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.