Quality Control Inspector II, Incoming Quality

BIOTRONIK; Singapore; On-site; SGD 36,000 - 58,000; Full time

Benefits offered by this job

Being entrepreneurial in spirit

Global teams and projects

Professional development

Job summary

BIOTRONIK is a leading medical devices company in cardiology, with operations in Singapore. The Quality Control Inspector II, Incoming Quality will oversee and perform incoming quality inspections in a clean room environment, aligned to BIOTRONIK specifications under cGMP and the Quality System.

You will analyze data, generate records, and support approvals and training as required. Role requires 2 years in a regulated manufacturing quality tech, familiarity with CMM/vision systems, and SAP/MES

Qualifications

• Quality inspections techniques and experience with measuring instruments.
• Familiarity with inspection tools like CMM, smart scope or vision systems preferred.
• Understanding of technical drawings and GD&T fundamentals.

Responsibilities

• Oversee incoming inspection operations in line with cGMP and QM requirements.
• Perform mechanical/visual/functional inspections per procedures and specs.
• Dispost non-conformities timely and block products for investigation.
• Generate inspection records for materials lots and NCRs as needed.
• Support First article/First Piece approvals and plan daily inspections.
• Maintain inspection records and archive documents as required.
• Assist in training and certification of inspection specs.

Skills

Quality inspections

Measuring instruments

Technical drawings

SAP experience

MES experience

Communication

Education

GCE O Level / ITE / NITEC

Tools

SAP

MES

Job description

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Quality Control Inspector II, Incoming Quality 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 II, 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

Location: Singapore | Working hours: Full-time

Job ID: 62301 | Contact: Human Resources

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.