QA Engineer 2

4 weeks ago

George Town, Malaysia Dexcom Full time

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

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.

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.

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