Our client is a leader in manufacturing of microscopy instruments.
Provide Quality Engineering support for Manufacturing Operations and resolving Quality issues with Process Engineers using standardized investigation tools. Drive changes, improvements and implementing quality control strategies.
- Investigate manufacturing product quality and compliance issues (e.g. non-conformances, audit observations, customer complaints) for production processes based on engineering principles and problem solving methodologies.
- Partner with engineering team on root cause investigations and/or corrective actions, perform non-conformance investigations for review with engineering, assures documentation content is valid, provide regular progress reports and quality metrics to management and cross-functional stakeholders, including developing resolutions as needed to improve metrics achievement
- Review and analyse key Quality Indicators and collaborate with manufacturing department to proactively resolve non-conformances and operational issues
- Supervise employees and quality activities pertaining to the production of products and/or manufacturing processes in - and with quality /technical knowledge of - multiple production areas, depending on the complexity of the areas, in addition to conducting performance reviews, including resolving performance issues
- Drive Quality and Productivity improvement by participating in lean and continuous improvement initiatives and projects
- Review, update and maintain risk management files
- Keep abreast of improvement tools, such as 5S, DMP, SW, and TPI to drive continuous improvement with sustainable results
- Adhere to company EHS requirements, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others
- Degree in Mechatronics/Mechanical Engineering/Electronics.
- Minimum 5 years relevant working experience in an assembly operations/engineering environment.
- Good knowledge of various statistical control method and strong background in QMS 9001. Familiar with ISO13485, USFDA QSR/cGMP (21 CFR Part 820) and ISO14971 for medical devices is a plus.
- Computer literacy in MS Office modules and Lotus Notes.
- Strong analytical and problem-solving skills.
- Knowledgeable in lean and investigation tools such as 8D and fish bone diagram
- Substantial understanding and knowledge of principles, theories and concepts relevant to Engineering
Please contact Ewen Poh at +65 6950 0365 or firstname.lastname@example.org for a confidential discussion
EA License no: 16S8066 | Registration no: R1550486
Only successful candidates will be notified.