Manager QA Engineering 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

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Compliance, Manufacturing, Production Processes, Technical Support, Root Cause Analysis, Statistical Tools, FMEA, CAPA, Auditing, Documentation, Team Leadership, Communication, Problem Solving, Process Improvement, Risk Management

Industry

Medical Equipment Manufacturing

Description

Provides technical support for the projects, functions, and strategic objectives of quality. 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. Provide guidance on NCMR dispositions and investigations and guidance on the CAPAs. Develops, implements, and maintains technical quality assurance, control systems and activities. Defines and specifies the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, and reliability of company products. Participates in the reviewing of engineering designs to contribute quality requirements and considerations. Strong tactical decision-maker handles unforeseen issues as they relate to organization's compliance with regulations. Understand domestic and international Quality System Requirements and how they interact to provide quality guidance to other departments and companies. Establishes operational objectives and work plans for the Quality Department and delegates assignments to subordinates. Specifically, assuring subordinates are meeting sustaining project deliverables, creating communication between cross-functional departments, participating in the process or product investigations, identifying potential root causes, and providing business solutions. Supports complex, cross-functional quality issues in a variety of subject matter areas and drives resolution and proactive solutions to customer complaints Providing technical guidance determining failure mode effects and analysis (FMEA). Utilizes quality feedback data from customers and consumers to drive continual improvement activities needed to achieve department strategic goals. Reviews data on product defects, product response plans, and product dispositions; recommends and implements improvements. 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. Supervise team in terms of costs, methods, and staffing. 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. Regularly interacts with different levels of the organization on matters regarding organization's compliance with regulations. Actively participate as a core team member of sustaining management team (Process Engineering, Operations, and Quality Assurance). 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 degree with 5 years equivalent industry experience; ; or a PhD with 2 years of related experience; or equivalent combination of education and experience. Also required 2-5 years of management experience or lead. At least 3 years of hands-on experience with high-volume manufacturing and equipment development for assembly and automation systems. 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 Manager QA Engineering is responsible for planning, implementing, and managing compliance of manufacturing processes with safety and quality standards. They also provide guidance on investigations and develop quality assurance systems.