- Design, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
- Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.
- Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
- Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- May assure compliance to in house and/or external specifications and standards (i.e. GLP, GMP, ISO Six Sigma).
- May supervise and administer specific aspects of the quality system.
- Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibration, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
- Leads or participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.
- Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
- Designs and performs Equipment, Process, Software and Test Method Validations.
- Applies risk management, validation, sample size, and external standards review and implementation activities.
- Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
- Assists with investigation and disposition of nonconforming materials with the Materials Review Board.
- Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
- Reviews schematics and mechanical drawings.
- Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab).
- Assumes and performs other duties as assigned.
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Engineer Systems Engineering
Found in: Talent MY C2 - 3 days ago
Infineon Technologies George Town, Malaysia Full timeIn your new role you will: · Develop test cases and methodologies for systems-level pre-silicon and post-silicon verification activities · Execute test cases and generate execution reports for systems-level pre-silicon and post-silicon verification activities · Perform hardware d ...
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Engineer Systems Engineering
Found in: Talent MY C2 - 3 days ago
Infineon Technologies George Town, Malaysia Full timeIn your new role you will: · Develop test cases and methodologies for systems-level pre-silicon and post-silicon verification activities · Execute test cases and generate execution reports for systems-level pre-silicon and post-silicon verification activities · Perform hardware d ...
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Found in: Talent MY C2 - 3 days ago
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Found in: Foundit MY A2 - 2 days ago
Celestica Electronics (S) Pte Ltd Penang, Malaysia Full timeGeneral Overview · Functional Area:Engineering · Career Stream: Design - Software Engineering · SAP Short Name:ENG-ENG-DSE · IC/MGR: Individual Contributor · Direct/Indirect Indicator:Indirect · Summary · The Engineer, Software develops, debugs, tests, deploys and supports code ...
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Reliability Engineer
Found in: Foundit MY A2 - 3 days ago
Celestica Penang, Malaysia Full timeReq ID: 119618 · Remote Position: No · Region: Asia · Country: Malaysia · State/Province: Bayan Lepas · City: Penang · General Overview · Functional Area: Engineering · Career Stream: Design Engineering Systems Applications · SAP Short Name: ENG-ENG-DSA · Job Level: Level 07 · IC ...
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Product Engineer
Found in: Foundit MY A2 - 3 days ago
Agensi Pekerjaan EPS Consultants Sdn Bhd Penang, Malaysia Full timeClient Background: MNC Company · Industry : Manufacturing · Location: Bayan Lepas, Penang. · Headcount: 1 · Position Title: Product Engineer · Tenure: Permanent · Remuneration: RM5K-RM8K · PRINCIPLE DUTIES AND RESPONSIBILITIES: · - Actively involves product transfer of new mode ...
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NPI Engineer
Found in: Foundit MY A2 - 3 days ago
Agensi Pekerjaan EPS Consultants Sdn Bhd Penang, Malaysia Full timeProduct Development Support: The NPI Engineer works closely with the product development team to provide input and technical expertise during the design and development phase of new products. They may offer suggestions for design improvements, manufacturability, cost optimization ...
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Process Engineer
Found in: Foundit MY A2 - 2 days ago
Flex Penang, Malaysia Full timeTo support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Process Engineer located in Bukit Minyak, Penang. · What a typical day looks like: · - Understand the manufacturing process, technologies, techniques and the product. ...
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BPEN_Manufacturing Engineer
Found in: Foundit MY A2 - 4 days ago
Bruker Penang, Malaysia Full timeBruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker's high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials ...
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Reliability Engineer
Found in: Foundit MY A2 - 3 days ago
Celestica Penang, Malaysia Full timeReq ID: 120136 · Remote Position: No · Region: Asia · Country: Malaysia · State/Province: Bayan Lepas · City: Penang · General Overview · Functional Area: Engineering · Career Stream: Design Engineering Systems Applications · SAP Short Name: ENG-ENG-DSA · Job Level: Level 07 · IC ...
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Thermal Engineer
Found in: Foundit MY A2 - 3 days ago
Celestica Electronics (S) Pte Ltd Penang, Malaysia Full timeGeneral Overview · Functional Area: Engineering · Career Stream:Design Engineering Hardware · SAP Short Name: AST-ENG-DHW · Job Level: Level 06 · IC/MGR: Individual Contributor · Direct/Indirect Indicator: Indirect · Summary · Hardware Design Engineer works with cross function ...
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Facilities Engineer
Found in: Foundit MY A2 - 1 day ago
Dexcom Penang, Malaysia Full timeAbout Dexcom · Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transformin ...
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Reliability Engineer
Found in: Foundit MY A2 - 3 days ago
Celestica Electronics (S) Pte Ltd Penang, Malaysia Full timeSummary · Systems & Applications Design is an interdisciplinary field of engineering that works with cross functional teams of other engineers, customers, supply chain and project leadership to ensure robust and high quality product development. · The Engineer, Systems/Applicatio ...
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Project Engineer
Found in: Foundit MY A2 - 3 days ago
Agensi Pekerjaan EPS Consultants Sdn Bhd Penang, Malaysia Full timeJob Responsibilities: · Schedule preparation, pre-planning and resource forecast for engineering and other technical activities relate to the project. · Attend site visit prior to project kick off, project meeting whenever required. · Oversee performance of vendors involved duri ...
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Engineer, Software
Found in: Foundit MY A2 - 3 days ago
Celestica Electronics (S) Pte Ltd Penang, Malaysia Full timeGeneral Overview · Functional Area:Engineering · Career Stream: Design - Software Engineering · SAP Short Name:ENG-ENG-DSE · Job Level:Level 07 · IC/MGR: Individual Contributor · Direct/Indirect Indicator:Indirect · Summary · The Engineer, Software develops, debugs, tests, depl ...
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QAE Engineer
Found in: Foundit MY A2 - 4 days ago
Ambu A/S Penang, Malaysia Full timeResponsibilities · Handle customer's feedback/ complaints, conduct failure investigation, work with site engineer to perform simulation where required, to resolve quality feedback. · Involved in product review revalidation, CAPA activities as assigned. · Compile investigation r ...
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Project Engineer
Found in: Foundit MY A2 - 3 days ago
Agensi Pekerjaan EPS Consultants Sdn Bhd Penang, Malaysia Full timeResponsibilities & Requirements: · Able to handle projects and work with the project manager to create a project plan and outline the resources needed to complete each phase of the project. · Asist project supervisors to understand each component contribution to the project till ...
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Industrial Engineer
Found in: Foundit MY A2 - 1 day ago
Bruker Penang, Malaysia Full timeAs one of the world's leading analytical instrumentation companies, Bruker Corporation covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, to accelerate time-to-market ...
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Engineer (BIM)
Found in: Foundit MY A2 - 1 day ago
Agensi Pekerjaan EPS Consultants Sdn Bhd Penang, Malaysia Full timeRESPONSIBILITIES: · Able to understand relevant drawings, working procedures and requirements. · Plan, managing and deliver the documents in compliance with the project's requirement on all aspects of design, including criteria, detailed design, term of construction and contract ...
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Process Engineer
Found in: Foundit MY A2 - 3 days ago
Keysight Technologies Penang, Malaysia Full timeis on the forefront of technology innovation, delivering breakthroughs and trusted insights to the world's visionaries and innovators in electronic design, simulation, prototyping, test, manufacturing, and optimization. Our 15,000 employees create world-class solutions in communi ...
QA Engineer 2 - George Town, Malaysia - Dexcom
Description
Summary:
Position may be responsible for various aspects of Quality Engineering, including supervision of support personnel and/or administration of specific aspects of the quality system. Job tasks require interfacing with all functions (Operations, Quality Assurance, Engineering, Regulatory Affairs, Clinical Affairs, Biometrics, Marketing, Legal, Finance, Sales, Customer Operations, Human Resources and upper levels of management). Personnel in this role must be systematic, highly organized and articulate and work in a team environment. A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
Essential Duties and Responsibilities
Education and/or Experience:
Bachelor's degree and minimum 5 years of related experience; or 3 years and a Master's degree; or a PhD without experience; or equivalent combination of education and experience. Medical Device experience preferred.
