Senior Quality Engineer (Medical Device Manufacturing) 

THE INDIVIDUAL

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.

 

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About Charterhouse

Charterhouse is a boutique executive search firm with footprints in Asia, Australasia and the Middle East. We offer professional and bespoke contingency search services across a variety of industrial sectors.

For more information on how we can help you, give us a call for a confidential discussion at (65) 6435 5600.