Staff Quality Engineer Jobs

Prepare PPAP documentation as required for product development, qualification, and product change management.

Working knowledge of ISO 26262 compliant safety management system and FMEDA

Working experience on execution of qualification per AEC Q100 requirements

Interface with contract manufacturers on compliance management of discrepant materials.

Comprehend and advocate customer quality expectations and fit-for-use requirements as applied to company’s products and business processes.

Support customers with automotive safety compliance requirements per ISO 26262.

We offer great benefits, including a 100% remote work environment, flexible schedules, and ongoing growth opportunities

Proven experience configuring and utilizing QA/QC management reporting tools, such as Zephyr or XRay

We are a remote-first, geographically-distributed team open to candidates from around the world

Progressive experience in software testing with a history of technical leadership roles

Excellent analytical, critical thinking, and problem-solving skills

Strong communication skills and an ability to collaborate cross-functionally

Support software build, maintenance, defect management, and change control activities.

Quality Management System ISO 13485

Knowledge of and experience with FDA General Principles of Software Validation

Experience in interpreting industry standards for medical device development and updating processes and procedures preferred.

Must be able to handle multiple tasks/projects and manage priorities accordingly.

Provide support to cross functional teams to ensure software quality objectives are met for medical device software development.

Self-managed and ability to work in a fast-paced, remote environment. Effective time management and prioritization skills.

Implement and manage changes to ensure overall program goals are achieved.

Experience in leading teams without direct authority.

Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint. Effective presentation skills.

Will consider remote locations for:

Responsible for global process and the associated policies and procedures.

Reports on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews

Minimum of 1 year supervisory/management or project leadership experience.

Minimum of 5 years supervisory/management experience is preferred

Proven process development and project management skills

Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

Ensures site audit readiness and hosts the Quality System audits; prepares and executes Quality Management System reviews

Review and approval of change management activities, challenges change effectiveness and drives strong review.

Responsible for initiation, management and support of ship, product Holds, potential product escapes.

May deputize proficiently for management in temporary absence, periodic review boards, business meetings etc. on a regular basis.

4+ years’ experience working in quality, manufacturing, engineering or in a highly regulated environment.

Knowledge of Risk Based and statistical concepts

Experience interacting with suppliers is a plus

Utilizing Lambda for new development and maintenance of manual test plans/test cases managed in TestRail

Participate in knowledge sharing sessions, and present test engineering solutions to others

Become an authority on Web, Mobile Web, Native Application, API/Backend, ADA compliance testing

Help define and drive testing process with Confluence across multiple platforms and teams

Partner closely with Development and Product teams to groom, estimate, plan and drive sprint deliverables using Postman and Confluence

Test all components of Web, Mobile Web, Native Application, API/Database using Postman and Lambda

Support the development of quality requirements to become part of Tesla’s global operating standards

7+ years of quality and/or design engineering experience in manufacturing or a manufacturing-related industry

Experience developing process / quality plans and audit procedures and driving failure analysis efforts and corrective actions

Experience in automotive high-volume quality manufacturing engineering or process engineering a plus

Evaluate quality risks and opportunities early in the program development phase

Maximize initial vehicle quality by partnering with cross-functional teams to evaluate line and process designs during early concept phases

Good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements

Maintain relevant documentation to comply with quality standards and customer requirements.

Investigate and implement corrective and preventive actions (CAPAs) to meet business and compliance requirements.

Reports verbally and in writing to the Director / Manager regarding the progress and results of projects.

Participates with the Director / Manager in the preparation of divisional, departmental, and project goals.

Assists the Director / Manager in presentations of technical nature when requested.

Ensures compliance to supplier management business processes.

Minimum six (6) years of experience in a Quality role supporting consumer products or equivalent

Strong interpersonal, written, and verbal communication and analytic skills

Experience with working with external manufacturers

Managed compliance profiles of various regulatory classes, i.e. cosmetics, OTC/drug, medical device, and food/dietary supplements

Minimum of a Bachelor’s degree or equivalent in science related discipline

2 to 3 Years experience working in a similar industry

Strong organizational and communication skills

Review Quality Records for completeness and accuracy.

Update QA Records logs and databases, maintains Qualified Personnel Records.

Scan Quality Records Files and close Quality Record Packages.

File active Quality records. Maintain Training Records file.

Quality Advocacy and Project Management.

Minimum 12+ years of working experience in Quality Engineering, or in manufacturing environment, or equivalent education and experience.

Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:

Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.

Minimum Education: Bachelor’s degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.

Understands CFR 21 820/ ISO 13485 requirements for making process or design changes.

Excellent communication and customer skills, problem solving, conflict management, time management and interpersonal skills required.

Deep knowledge and experience with the CentOS/RedHat operating system in large-scale production environments

6+ years of experience in Performance Engineering / Testing, and/or Tools Development teams for the Enterprise

Hands on experience on benchmarking system performance, database performance analysis, capacity sizing and optimization.

Strong problem-solving and analytical skills with an aptitude and passion for learning new technologies.

BS/MS Degree in Computer Science with solid experience developing and deploying mission critical softwar

Minimum 5-8 years of mechanical engineering experience.

Minimum 2 years of amusement park experience; 1 of which should be the inspection of rides.

Experience with the maintenance of complex systems that meet regulatory and industry standards.

Experience with investigations, root cause analysis, and hazard assessments.

Confirmed knowledge of AutoCAD and MS Office.

Excellent written and verbal communication skills with an ability to present intricate data relationships in concise and straightforward presentations.