We are seeking an experienced Quality Engineer to join our team on an 18-month contract with a possibility of extension or permanency. This role will be based onsite, Monday to Friday, with standard office working hours. The successful candidate will have a junior-mid level profile of experience, ideally coming from a regulated manufacturing environment.
Job Responsibilities:
* Supervise and guide Quality Technicians in their daily tasks.
* Develop and implement process improvements to ensure predictable processes across all product lines. This includes risk reduction, yield improvements, customer complaint reduction, error proofing, cost reduction initiatives, and process automation activities.
* Provide effective and responsive quality assurance support to Operations to meet their objectives of quality, cost, and output.
* Ensure that all process variables and interactions are adequately defined. Identify and address all failure modes in the process using DOE studies and FMEA's.
* Drive and implement plant-wide quality system improvements.
* Ensure regulatory compliance in the area of responsibility, adhering to cGMP's of all medical device regulatory agencies such as FDA and TUV.
* Provide functional expertise to other support functions on quality-related issues such as regulatory requirements, statistical techniques, and sampling principles.
* Implement statistical techniques to monitor process performance, including SPC, CpK analysis, and sampling techniques.
* Approve change requests for products, processes, and quality system changes.
* Conduct customer complaints analysis, approval of analysis reports, and analysis of complaint trends.
* Define and execute validation plans, protocols, and reports approval for processes, products, and test methods.
* Compile regulatory documentation, including design files, product transfer files, and essential requirements.
* Perform internal quality audits.
Requirements:
* Bachelor of Science degree in Engineering or Technology.
* Minimum 2-3 years' experience in a manufacturing environment or equivalent with direct experience in QA, preferably in a GMP-regulated environment.
* Experience in the medical device industry is advantageous.
* Previous experience on automated or high-volume production lines is beneficial.