Quality Control Inspector/Technician

BIOTRONIK APM II PTE. LTD.; Singapore; On-site; SGD 42,000 - 60,000; Full time

Benefits offered by this job

Entrepreneurial mindset encouraged

Global teams and projects

Professional development

Job summary

BIOTRONIK APM II PTE. LTD. is seeking a Quality Control Inspector/Technician to oversee and execute quality operations in a clean room environment.

You will ensure incoming inspections comply with BIOTRONIK specifications under cGMP and quality systems. The role involves data analysis, non-conformity handling, and documentation in QM systems. The ideal candidate has 2+ years in quality roles, familiarity with CMM/vision measuring equipment, and proficiency in SAP or MES.

Qualifications

• Formal engineering education or equivalent.
• Experience in quality technician role in regulated manufacturing is a plus.

Responsibilities

• Oversee incoming inspection operations according to cGMP and QM requirements.
• Perform inspections against procedures, work instructions, drawings or specifications.
• Disposition of non-conformities and block products for investigation as needed.
• Conduct mechanical, visual, functional inspections on materials and assemblies to meet specs.
• Support First Article/First Piece approvals and prioritize inspections per schedule.
• Label, inventory, and record inspection data and defective storage locations.
• Generate detailed inspection records and non-conformance reports.
• Train and certify staff on inspection specifications.
• Monitor QM compliance and verify issues in production areas.
• Manage inspection records and archiving of documents.
• Assist projects and other tasks as directed by engineers or supervisor.

Skills

Quality inspection techniques

Measuring instruments handling

Reading technical drawings

Education

GCE O' Level / NITEC in mechanical, mechatronic or related engineering

Tools

SAP

MES

CMM

Smart Scope

Vision measuring system

Microsoft Office (Outlook, Word, Excel, PowerPoint, SharePoint, Teams)

Job description

The Quality Control Inspector/Technician, is responsible for overseeing and executing quality operations related activities, including measurement, and testing at Incoming quality. To ensure that the incoming inspection operations complies with the products quality standards, per BIOTRONIK specifications under cGMP and Quality System rules.

The Quality Control Inspector/Technician, who is stationed in a Clean Room environment, will assists in overseeing the incoming inspection operations, obtaining and analyzing the quality data for materials/components related controls.

Your Responsibilities

• Oversee the incoming inspection operations based on cGMP and Quality System requirements.
• Perform inspection or operational processes compliance against the established procedures, work instructions, drawings and/or specifications.
• Timely disposition of Non-conformities, including the blocking of products for further investigation.
• Perform mechanical, visual, functional inspection, which including but not limiting to: Raw materials, components, fabricated/manufactured parts & assemblies, to ensure all quality aspect of the delivered parts met the specifications and requirements.
• Responsible for supporting First article/First Piece approval process and prioritize daily and weekly inspection based on planned scheduled.
• Labeling, inventory, and bookings of data and defective product storage locations in accordance with the QM specifications.
• Generate detail inspection records for incoming materials lots, and non-conformance report as necessary.
• Training and certification of inspection specifications in accordance with inspection specifications
• Continuous monitoring and planned verification of issues, processes, etc. on QM specifications compliance, in the corresponding production area.
• Management of Inspection Records and other documents which may require archiving.
• Support projects and any others activities as directed by engineers or supervisor.

Your Profile

• At least GCE 'O' Level, ITE/ NITEC in the field of mechanical, mechatronic, or other engineering discipline or equivalent.
• At least 2 years of experience in quality technician role in a regulated manufacturing environment will be an advantage.
• Microsoft Outlook, Word, Excel, Powerpoint, Sharepoints, Teams.
• Quality Inspections techniques and experiences in handling measuring instruments.
• Experience in incoming inspections tools i.e CMM, smart scope, vision measuring system preferred.
• Basic Quality Analytical Tools.
• Experience with SAP and MES preferred (Manufacturing Execution Systems).
• Comprehending Technical Drawings.

What we offer

• being encouraged to think and act entrepreneurially
• working in global teams and projects
• developing yourself professionally