Quality Engineer Eumdr

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team 

Who we are looking for:

Stryker are looking to onboard a Quality Engineer who under general supervision undertake tasks related to the maintenance and enhancement of the ISO13485 approved Quality System.

What you will do:

·Taking direction from Quality Engineer’s/Quality Team Leader as to how best to deploy resources and effort on the operations floor.

·Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.

·Daily production line monitoring and the identification and quantification of process problems, along with subsequently implementing the necessary improvements and/or controls

·Regular communication with the Manufacturing Team Members regarding issues, concerns and watch-outs on the lines.

• Actively interfacing with cross-functional team members and suppliers, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets

Inspection

• Assist in the develop and maintainance of sampling and inspection procedures
• Sample, inspect and record inspection results when required
• Control movement of components / products following inspection
• Conduct MRB forums

Quality Improvements

• Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
• Support implementation of plant wide quality system improvements.
• Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.
• Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.

Manufacturing Support

• Support Manufacturing Cell in addressing Quality Metrics, e.g. e.g. CAPA, Validations, NCR, Quality Awareness Tests, Training, ECR’s and Internal Audit Findings.
• Responsible for input to Quality Metrics
• Participate in the development and Continuous Improvement of the manufacturing processes for existing and new products. Coordination of PPAP activities.

• Provide functional expertise to other support function on quality related issues.
• Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
• Coordination of MRB activities to the business unit to ensure the timely assessment of potential non-conforming products.
• In conjunction with Team Lead approval, has the authority to order the cessation of production and product shipments in the event of a non-conformance arising. In conjunction with Team Lead approval, also has the authority to order the recommencement of production provided he/she is satisfied that all issues pertaining to the non-conformance have been addressed.
• Support the creation & presentation the Monthly Business Unit review Slides and Represent Quality at this forum.
• Represent Quality at the Weekly FPY (First Pass Yield) forum; Review the FPY Slides for trends and update as required from a Quality perspective

Customer Complaints

• Give input into the evaluation of Customer Complaints (PER Investigation) as required.
• Problem solving / Trouble shooting of customer complaint investigations, coordination of root cause and risk assessments associated NC’s and Risk Assessments where required.

NCR/CAPA

• Support the NCR/CAPA Process.
• Participate in risk assessment activities and ensure that all failure modes in process have been identified and addressed.

• Participate in Problem Solving meetings using the following: 4D, Six Sigma, etc.
• Ensure that Containment of product is properly addressed and Documented
• Ensure that Corrective Actions clearly actioned and documented.

Validation

• Assist in completion of equipment validation ((VP, IQ, OQ, PQ, MSA, IPF’s, PSP’s, FR’s etc.).
• QA review and approval of unplanned Pemac routines.

Auditing

• Participate in Internal Audits as required and Supplier Audits. if required.

• Support site during External Audits. (i.e. FDA, IMB and BSI).

Risk:

• Understand and ensure compliance to ISO 14971 ‘Risk management’.
• Ensure that the Top Down Risk Documents, Bottom Up Risk Documents and Attribute Charts are current and live.

What you will need:

• Must have completed Degree or be working towards completion of Degree in Engineering, Science or equivalent (NFQ level 7)

• Minimum of 1-2 years experience in a QA role.

• Good level of technical and analytical skills.

• Working knowledge of statistical techniques, green /black belt six sigma an advantage

• Problem Solving Skills and ability to handle multiple tasks in a fast paced environment.

• Capable of working as part of a multi discipline team.

• The individual should enjoy working in an aggressive, dynamic and results motivated team environment.

• High level of PC skills required. Excellent Communicator

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.