- The Quality Engineer assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensures that performance and product quality conforms to established company, customer and regulatory requirements. Assists in the review, analysis and reporting on quality discrepancies related to assembly and process. May investigate problems and recommend disposition, modification and corrective action for reoccurring or non-recurring discrepancies.
Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):
- Support release of assembly batches including offline testing, paperwork, stratified samples management.
- Update and creation of work instructions as required.
- Support of validation and metrology activities.
- Drive changes in process to minimise risk of error in paperwork, sampling or testing.
- Work with team leader, QA Inspectors, line Co-ordinators and batch release specialist to ensure all steps of batch completion and release are defined and executed consistently.
- Be point of co-ordination for all quality issues between automation and moulding.
- Set-up process to log, track and resolve issues seen.
- Drive specific issues to resolution.
- Determine opportunities to pro-actively drive product quality improvement though process or procedural changes.
- Support all company safety and quality programs and initiatives.
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
- Excellent IT, Communication, Interpersonal and presentation skills
- Ability to work off own initiative and as part of a cross functional team.
- Desire to learn new tasks
- Performance and results driven
Job Specifications : The minimum education and experience required to perform this job competently.
- Level 8 Degree in Science / Engineering (Mechanical / Electronics / Chemistry) or related discipline. Or Level 7 in same disciplines coupled with 2/3 years relevant quality experience in a GMP environment.
Organization Linkages: List the titles of individuals and organizations with which this position has the most frequent and significant contact. Briefly describe the nature of those contacts.
- Reports to Senior Quality Engineer
- Quality Engineers
- Quality Team Members
- Operations and Managers
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