Quality Control à Malaisie

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:
Manages manufacturing plant quality programs, processes, activities, and Responsibilities: supporting current operations and new product introductions. Manages quality control personnel in the execution of their quality related duties. Interacts with other manufacturing departments (production, maintenance, engineering etc.) as well as with HQ support personnel, suppliers and other external parties on issues related to quality.

Responsibilities:
• Establish and maintain a manufacturing Quality Management System and team that contributes to outstanding customer service and promotes the highest standards for product quality.
• Plans, organizes, directs and reports on all quality assurance engineering related activities such as product components, manufacturing in-process controls, product release.
• Ensure incoming parts/materials are within specification and all required documents are complete and accurate.
• Identify QC test procedures and equipment required to maintain high product quality.
• Ensure suppliers are performing tolerance/specification testing, utilizing Insulet’s prescribed test methods, procedures and equipment.
• Make sure released product meets specifications and predetermined criteria to ensure Pod and sub assembly manufacturing is in compliance and control through lot Qualification process and procedures.
• Lead and execute root cause analysis to determine failure causes and implement failure reduction and elimination strategies.
• Suggest methods for improving product quality, design, or manufacturing processes
• Develop and/or manage quality programs and training, complete with tools and processes that support an operational excellence environment and ensure compliance with all company and Federal audit requirements.
• Establish key quality KPI’s and score carding/tracking mechanisms to ensure continuous improvement.
• Manage existing and create new, if necessary, quality gates to ensure Incoming Quality Assurance, Pod and sub assembly manufacturing are in compliance and control.
• Ensure plant policies and procedures are in compliance with all FDA regulations.
• Engage with suppliers and supplier development group in monitoring supplier quality performance.
• Serve as a team member and leader to provide quality expertise to other manufacturing functional teams.
• Work cross functionally with HQ and field personnel to promote understanding and cooperation for the quality agenda.
• Lead all quality and regulatory inspections and audits, as well as the completion of all action items in a timely manner.
• Maintain all internal and external quality documents and prepare required reports in a timely manner.
• Develop and implement training programs and best practices required to maintain high quality standards.
• Performs other duties as assigned.

Education and Experience:
Minimum Requirements:
• BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.
• Minimum 5 years of experience in the FDA regulated environment.
• Experience in Quality in an FDA regulated industry.

Preferred Skills and Competencies:
• Have knowledge, experience and understanding of the tenets of Six Sigma Process and other statistical analysis tools (SPC) required to maintain high standards. Six Sigma black belt preferred.
• Have knowledge and understanding of ISO programs.
• High proficiency with software that is centered on process management and statistical data analysis.
• Successful experience in factory level quality, production and / or maintenance management.
• Effective verbal and excellent technical writing skills.
• Ability to communicate at multiple levels of an organization.
• Ability to organize and judge priorities.
• Excels at generating and maintaining organized and accurate records.
• Knowledge of Quality principles using statistics and SPC tools.
• PC skill, word processing, spreadsheet, database.
• Able to work effectively in a high-stress, high-energy environment.
• Able to make effective decisions quickly based on vague or imperfect information.
• Great interpersonal skills.
• Track record of leading positive change.