Job Descriptions
Who we want:
• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Position Summary
The Acceptance Activities Quality Engineer will collaborate between Quality Assurance and Manufacturing. This person will provide expert QA support to Operations, in ensuring goals and objectives are achieved for the plant.
What you will do:
- Development of acceptance and inspection activities.
- Carry out Lot release review.
- 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 and calibration to ensure that all equipment required for acceptance and inspection activities is sufficient and maintained appropriately.
- 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 appropriate direction and training in relation to acceptance and inspection activities.
- 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 devices regulatory agencies (i.e. FDA, IMB and BSI).
- Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ).
- Ensure compliance of QMS procedures within the Business Unit.
- Participate in the development and 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.
- Interface with Suppliers for new processes, quality Issues and Process Improvements.
- Support site during External Audits. (i.e. FDA, IMB and BSI).
- Responsible for input to Quality Metrics.
What we are looking for:
- Degree in Engineering, Science or equivalent is required.
- Minimum of 2 years 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.
- Previous experience in Lot release review would be an advantage
- Previous experience in Development of acceptance and inspection activities would be an advantage
