Supplier Quality Engineer

Insulet Malaysia SDN. BHD.; Malaysia; In loco; MYR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

Insulet Corporation in Malaysia is seeking an Engineer, Supplier Quality to support supplier selection, qualification, and ongoing management to ensure products meet Insulet quality standards. The role interfaces with internal teams and suppliers to communicate metrics and drive continuous improvement.

The position requires a Bachelor’s in engineering or science and 2–5 years in medical device quality, with fluency in English and Malay.

Competenze

• BS degree in engineering/science or equivalent experience.
• 2–5 years of quality assurance experience in a regulated medical device environment (FDA/ISO).
• Experience with Design Control and related documentation.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971; EN 60601/ISO 62304 is preferred.
• Auditor training certification to ISO 13485/17025 or equivalent preferred.

Mansioni

• Support selection, qualification, and management of suppliers.
• Assist qualification of new suppliers, components, and changes with cross‑functional plans.
• Maintain supplier audit reports and supplier profile records.
• Develop supplier audit schedule and execute scheduled audits.
• Prepare audit reports and communicate quality issues to suppliers for corrective actions.
• Track supplier performance via scorecards and CAPA follow‑ups.
• Support site during external audits (BSI, FDA, Customer).
• Participate in training and other duties as assigned.
• Oversee Design Control to ensure regulatory and quality compliance for current and new products.

Conoscenze

Quality Assurance

Medical devices

Auditing

Regulatory compliance

Documentation management

Communication skills

MS Office

Formazione

Bachelor's degree in engineering/science

Strumenti

MS Word

MS Excel

MS PowerPoint

MS Access

Descrizione del lavoro

Job Summary Responsibilities

Reporting directly to the Manager, Supplier Quality, the Engineer, Supplier Quality is responsible to support the selection, qualification, and management of suppliers. Closely works with suppliers to ensure product/service quality meets lnsulet requirements. Interfaces with other Insulet departments/functions as well as with suppliers and other external parties on issues related to product/service quality. Effectively communicates Quality metrics through supplier scorecards and Management Review to the organization, suppliers, and Executive Management.

• Maintain approved supplier list and supplier history records in accordance with quality system requirements.
• Assist with the qualification of new suppliers, new components, and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of plans and requirements for such qualifications.
• Maintains accuracy of Supplier Audit Reports and Supplier Profile.
• Develop and maintain the Supplier Audit Schedule to ensure supplier audits are scheduled per internal procedure.
• Plans and conducts scheduled audits of suppliers to assess compliance with lnsulet Requirements.
• Prepares Audit Reports to document audit findings and observations.
• Communicates quality issues to suppliers as needed and provides assistance to develop corrective actions.
• Initiate and follow up on supplier CAPA for both audit deficiencies and internal non-conformances to ensure timely closure and effectiveness.
• Generates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility.
• Tracks and trends supplier performance via supplier scorecards, taking remedial action as needed.
• Conduct and assist with internal audits.
• Assist or leads CAPA evaluation and closure as related to the supplier quality processes and or supplier performance.
• Participate in developmental and departmental training.
• Support Site during external audits (i.e. BSI, FDA, Customer).
• Performs other duties as required.

Requirements

• Bachelor's degree (preferably science or engineering discipline) required.
• 2 to 4 years of experience in quality in the medical device industry.
• Fluent in both English and Malay language.
• Ability to communicate and work effectively at multiple levels within the organization and with external business partners.
• Good interpersonal skills in dealing with suppliers, peers and other functional areas.
• Working knowledge of ISO 13485 quality system standards.
• Auditor training certification to ISO 13485, 17025 or other industry QMS Standard preferred.
• The ability to prioritize multiple competing deliverables simultaneously.
• Must be proficient in Word, Excel, Outlook and Power Point.

Position Overview

This position is responsible for Design Control to ensure current products and new projects meet the regulatory and quality requirements for medical devices. Interfaces with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support. Effectively communicate design and development regulations, optimizing development, review and/or approval of design documents and protocols and ensuring ambiguities and conflicting requirements are resolved are critical to the success of the position.

• Responsible for Design Control initiatives to develop appropriate Design History File documents.
• Review and approve new product documentation, as required.
• Collaborate with Project Management to optimize Design Control process and develop Sustaining Quality Engineering process.
• Review and approve Design Control documents and protocols.
• Serve as the Design Control expert to organization.
• Develop and deliver Design control training for organization.
• Support CAPA activities.
• Support Risk Management activities and ensure compliance to standards and regulation.
• Performs other duties as assigned.

Education and Experience

Minimum Requirements:

• BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience.
• A minimum of 2-5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
• Experience in the development and implementation of effective Design Control Systems.
• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices.
• Working knowledge of EN 60601, Safety requirements for medical electrical systems.
• Working knowledge of ISO 62304, Medical Device Software – Software Life Cycle Process.
• Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint).
• Demonstrated experience organizing and maintaining large documentation sets.
• Ability to follow up with task owners to close out open items.
• Familiarity with structured phase-gate product development processes.
• Familiarity with FDA, ISO, and other international regulatory requirements.

Preferred Skills and Competencies

• Effective verbal and written communication skills.
• Experience collaborating and communicate with individuals at multiple levels in an organization.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
• Skilled in computer use including word processing, spreadsheet, and database applications.
• Able to work effectively in a high-stress, high-energy environment.

Physical Requirements

• Travel as required to support business needs

Company Culture

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! Insulet Corporation is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights) Insulet employees are all focused on the same goal — to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers — leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.