Job Description

• Well Established Company
• Basic $3000 - $6000 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm
• Training Provided for those without/lesser experience

Job Responsibilities:

• Develop and maintain the process documentation: create and maintain detailed process documentation, including standard operating procedures (SOPs), work instructions, and process flowcharts. Ensure that manufacturing processes are well-documented and comply with relevant regulations and quality standards
• Collaborate with cross-functional teams, including R&D and Production Personnel, to select and implement appropriate equipment, tools, and technologies for manufacturing process. May involve evaluating equipment capabilities, conducting trials, and coordinating equipment validation activities
• Investigate and resolve manufacturing process issues, deviations, and non-conformities. Apply problem solving techniques, root cause analysis, and CAPA \xe2\x80\x93 corrective and preventive actions to address process-related challenges and ensure product quality and compliance
• Provide training and support to manufacturing personnel on current / new processes, equipment, and tools. Conduct training sessions, create training materials, and ensure that operators are knowledgeable about and follow established procedures
• Identify and mitigate process-related risks that may impact product quality, safety, or compliance. Collaborate with the risk management team to implement risk assessment and mitigation strategies
• Regulatory Compliance: Ensure adherence to relevant regulations and standards governing medical device manufacturing, such as ISO 13485 and FDA guidelines. Stay updated on regulatory requirements and participate in audits and inspections to maintain compliance
• Other ad hoc duties as assigned

Job Requirements:

• Possess minimum Diploma/Degree in Engineering (Mechanical / Electrical and Electronic / Production / Chemical Processing) or equivalent
• AUTOCAD drawing skill is an advantage
• Training Provided for those without/lesser experience

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632) EA Recruitment Pte Ltd EA License No: 21C0492