Senior Quality Engineer (Medical Device Manufacturing)

Job description

Job Summary

Our client is a leader in manufacturing of microscopy instruments.

Job Description

Responsibilities:

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

Requirements

• 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 charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.