Staff QA Engineer at Dexcom

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

10 Apr, 26

Salary

0.0

Posted On

10 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Compliance, Risk Management, Statistical Tools, Root Cause Analysis, FMEA, Validation, Technical Documentation, Auditing, Process Controls, Inspection, Training, Communication, Problem Solving, Manufacturing Processes, Medical Device Experience

Industry

Medical Equipment Manufacturing

Description

Designs, 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. Takes the initiative to develop systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs. 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. Responsible for reviewing, authoring, and revising appropriate technical documentation including design history file, standard operating procedures, protocols, reports, etc. 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. Provides technical guidance with respect to equipment, software, product, and process requirements including defining and identifying failure mode effects and analysis (FMEA) Applies risk management, validation, sample size, and external standards review and implementation activities. Assists with investigation and disposition of nonconforming materials with the Materials Review Board. Able to review schematics and mechanical drawings; this include read, write, and understand specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools. Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab). 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. Assumes and performs other duties as assigned. Bachelor's degree and minimum of 8 years of related experience; or Master's degree with 5 years equivalent industry experience; ; or a PhD with 2 years of related experience; or equivalent combination of education and experience.. Medical Device experience preferred. Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems). Must have strong communication, presentation, organization, planning, and the interpersonal skills necessary to work as a team member and act as a liaison with customers. Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel, Power BI, MiniTab/JMP) is preferable. Proficiency with statistical tools (Minitab, JMP, or equivalent) and hands-on experience in root cause analysis and corrective actions (8D, DMAIC) Deep knowledge of quality methodologies such as FMEA (DFMEA & PFMEA) or MSA & SPC

Responsibilities

The Staff QA Engineer is responsible for designing, implementing, and maintaining quality assurance protocols for manufacturing processes. This role includes leading audits, participating in design teams, and ensuring compliance with safety and regulatory standards.