Supervisor, Incoming Quality

Insulet; Gelang Patah; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading life sciences company is seeking an Incoming Quality Supervisor to oversee quality control for incoming materials. This role includes supervising a team, developing training plans, and ensuring compliance with industry regulations. The ideal candidate will have a strong background in quality assurance, previous supervisory experience, and the ability to analyze data for process improvements. Join us in making a difference in patients’ lives with our innovative products.

Qualifications

• Prior experience in quality control or assurance in a regulated environment.
• Strong organizational skills and attention to detail.
• Ability to handle conflicts and team dynamics effectively.

Responsibilities

• Supervise and mentor the quality control inspection team.
• Execute IQC procedures and manage inspections.
• Analyze inspection data for trends and improvements.

Skills

Leadership

Quality assurance

Process improvement

Technical writing

Education

Education in engineering or management

Experience in regulated industry

Tools

Microsoft software

Job description

Overview

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Position Overview:

The Supervisor plays an integral part of Insulet’s Quality Department as the leader of the Incoming Quality Assurance (IQC) supervisor, and as a leader who manages inspections activities in accordance with FDA-approved medical devices. The role requires strong organization skills and attention to detail while working in cross-functional teams to accomplish departmental and company goals.

As an Incoming Quality Supervisor, this role includes overseeing all aspects of quality control for materials entering a facility. They manage a team of inspectors to ensure that raw materials, components, and other goods meet specified standards before being used in production.

Responsibilities

• Team leadership and supervision: Supervise, mentor, and provide day-to-day direction for the incoming quality control (IQC) inspection team.

• Develop training plans and conduct training sessions for technicians on inspection procedures, quality standards, and safety.

• Create and distribute work assignments and testing priorities to ensure an efficient workflow.

• Monitor team performance against key performance indicators (KPIs), such as non-conformance rates and inspection throughput.

• Arrange and manage resources to ensure efficiency of the inspection area and on-time delivery.

• Inspection and quality assurance: Execute and implement IQC procedures, test plans, and sampling techniques.

• Inspect and approve incoming materials and components for compliance with specifications, using tools like calipers, micrometers, and CMMs (Coordinate Measuring Machines).

• Review inspection documentation for accuracy and compliance with quality protocols.

• Perform lots acceptance in system upon pass inspection.

• Ensure that all inspection equipment is properly maintained and calibrated.

Problem-solving and continuous improvement

• Manage the process for handling non-conforming materials, from quarantine to disposition.

• Lead or participate in root-cause investigations for quality issues found in incoming materials.

• Interface with supplier quality engineers to manage and resolve quality problems and implement corrective and preventive actions (CAPAs).

• Analyze inspection data to identify trends and recommend improvements to internal processes or supplier quality.

Documentation and compliance

• Maintain accurate and detailed records of all inspection activities and results.

• Prepare and present reports on quality metrics and inspection performance for management and other departments.

• Ensure the IQC department operates in compliance with internal policies, industry regulations, and quality management systems like ISO 13485.

• Participate in internal gemba walks and external audits to ensure compliance.

• Publish and report quality inspection data and performance.

Communication and collaboration

• Act as the primary point of contact for internal stakeholders related to incoming activities, such as engineering, production, and purchasing, regarding incoming material quality.

• Communicate with production staff and leadership to resolve quality-related questions and issues.

• Collaborate with other quality teams to ensure quality standards are met throughout the entire production process.

Qualifications and preferred skills

• Education and/or experience in engineering, technical, management or scientific discipline.

• Prior experience working in a regulated industry such as Quality System Regulations 21 CFR 820 and/or ISO 13485.

• Ability to handle team interpersonal conflicts and find an acceptable resolution.

• Effective verbal communication and excellent technical writing skills.

• Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision.

• Experience creating and analyzing trend and Pareto charts.

• Experience or certification in process improvement and ISO process controls.

• Excels at generating and maintaining organized and accurate records.

• Experience with Microsoft software.

• Prior supervisory / team leadership experience.