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Senior Quality Engineer (Medical Device Manufacturing)

Keywords / Skills : Quality, Medical

4 - 10 years
Posted: 2018-09-10

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.


Key Skill(s)

About Company

Charterhouse is an Australian owned executive recruitment consultancy, which has expanded its operations in Singapore in mid 2006. Charterhouse was formed by bringing together a number of the industry's most successful, experienced and professional, permanent and contracting recruitment consultants. By merging their vast, international experience the vision was to create a business built upon not just meeting expectations but consistently exceeding them, through dedication, passion and integrity.

Charterhouse offers specialist services within the Accounting, Banking & Finance, Sales and Marketing, Technology, Industrial, Manufacturing and Engineering fields.

4 Battery Road
Bank of China Building #33-01
SINGAPORE 049908
Tel: 65 6435 5600
Fax: 65 6438 1600
Email: apply@charterhouse.com.sg
Website: www.charterhouse.com.sg
Agency License Number: 06C3997
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