Job Description

Work Flexibility: Hybrid or Onsite

The Product Acceptance Engineer will be the primary contact between Quality Assurance and Operations in The Finished Goods Operations. This person will provide expert QA and scientific support to Operations, in ensuring goals and objectives are achieved for The Finished Goods Operations.

• Complete Lot Review and Release for The Finished Goods Operations.
• Complete Sterile load reviews
• Continuous improvement and development of acceptance and inspection activities in The Finished Goods Operations.
• Introduction of best practices in acceptance and inspection activities.
• Co-ordinate with business units to ensure that acceptance and inspection activities are appropriately carried out.
• Ensure that a consistent approach to acceptance and inspection activities is developed and maintained.
• Co-ordinate with the business units in relation to non-conformance activities and root cause analysis associated with acceptance and inspection activities, to ensure a consistent approach.
• Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
• Ensure regulatory compliance in area of responsibility to GMP of all medical device\xe2\x80\x99s regulatory agencies (i.e. FDA, IMB and BSI).
• Provide functional expertise to other support function on quality related issues.
• Own and drive NC/CAPA\xe2\x80\x99s related to process.
• Interface with Suppliers for quality Issues.
• Work cross functionally with such groups as Regulatory, Design Division and Operations to ensure all issues are successfully resolved.
• Support The Finished Goods Operations in addressing quality metrics, e.g. NC, CAPA, , , Process Changes, , Quality Alert, Product Holds and Recalls.
• Support site during External Audits. (i.e. FDA, IMB and BSI). Support / act as local subject expert for review, creation and training of divisional/corporate procedures.
• Responsible for input to Quality Metrics.
• Ensure system transactions
• Degree in Science or equivalent is required.
• Minimum of 4 years\xe2\x80\x99 experience in a QA role.
• Good level of technical and analytical skills.
• Problem Solving Skills and ability to handle multiple tasks in a fast-paced environment.
• Capable of working as part of a multi-discipline team across multiple continents and time zones.
• Previous experience in Lot Review and Release would be an advantage
• The individual should enjoy working in a fast paced, dynamic and results motivated team environment.
• The individual should be able to work independently to achieve desired goals and results.
• Competent in working with all Microsoft Office programs (Excel, PowerPoint & Visio etc).
• Previous experience with ERP systems (SAP, Oracle etc,) would be an advantage.
• Excellent Communicator.

Stryker