Sr 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, Manufacturing Processes, Production Processes, Internal Audits, Risk Management, Statistical Tools, Root Cause Analysis, Corrective Actions, FDA Regulations, ISO Standards, Communication Skills, Team Collaboration, Data Analysis, Inspection Procedures, Document Control

Industry

Medical Equipment Manufacturing

Description

Works on problems of more complex scope where analysis of situations or data requires a review of a variety of factors. Builds productive internal/external working relationships. 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). Involve in review, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Involve in designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. May supervise and administer specific aspects of the quality system. Some examples include Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training. Performs internal audits to ensure systems consistently comply with requirements and are effective, support external audits and drive closure of corrective actions. 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. Leads 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. Coordinates the disposition of nonconforming materials with the Materials Review Board. Able to review and understand schematics and mechanical drawings. Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools. Assumes and performs other duties as assigned. Bachelor's degree and minimum of 5-8 years of related experience; or Master's degree and 2-5 years equivalent industry 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)

Responsibilities

The Sr QA Engineer is responsible for planning, implementing, and managing compliance of manufacturing and production processes with safety, quality, and regulatory standards. They also perform analysis of reports and production data to identify trends and recommend updates to quality standards and procedures.