Quality Assurance Quality Control Engineer Jobs in California

Strong interpersonal skills with the ability to smoothly interact with all levels of management and employees

Educate, train, & advise company professionals to ensure compliance with RA requirements

BS degree in Engineering or a related field or equivalent experience required.

Strong knowledge of electro-mechanical systems manufacturing

Strong knowledge of statistical process control, IQ/OQ/PQ, CAPA, supplier quality, FMEA, six sigma tools, and Lean manufacturing techniques.

Hands-on experience dealing with FDA Inspections.

Oversee the Medical Device Reporting (MDR) decision-making process to ensure timely reporting and resolution of MDRs in compliance with FDA requirements

5+ years experience working under medical device quality systems

Ability to understand and clearly articulate FDA Quality System Requirements and guidance related to medical device and software development

Excellent verbal and written communication and collaboration skills with proficiency in technical writing

Digital therapeutics and startup experience is a big plus

You are comfortable working in a fully remote setting

Degree in Mechanical, Materials, or Biomedical Engineering with minimum 4 years of experience

Experience in 483 / Audit remediation for supplier-related problems.

Working independently with the internal and external stakeholders for execution.

Provides Quality Engineering support for commercial Medical products.

Apply various engineering principles including metallurgy, heat transfer, strength of materials, statics, sterilization, and biocompatibility.

Present technical data to groups within and outside the organization.

Perform project management of quality plans or other projects

Identify and implement Quality Management System improvements.

SupportRoute92Medical'seffortstosustainabestpracticeQualitySystemby ensuringcompliancetoregulatoryrequirementssuchasFDAQSR,ISO13485andtheEUMDR,andthatproductsmeetallapplicableinternalandexternalrequirements,fromnewproductconception, development, through productlaunch.

At least 3-4 years of experience as a Quality Engineer.

At least 2 years of experience in a medical device regulated environment.

Experience with sampling plans and other statistical methodologies.

• Experience with Microsoft Test Manager is required.

• 5 or more years of systems development and/or testing experience.

• Deeper understanding and knowledge of relational databases SQL Server 2016 or higher.

• Experienced in testing C# .NET Web applications.

• Experienced in testing in the Agile environment.

• Must have User Experience insight to leverage while testing.

Strong understanding of Quality Management System (ISO9001, AS9100) requirements

Help identify production line bottlenecks; communicate to the management team. Continuously identifies areas for improvement and presents project opportunities to management.

Advanced knowledge of continuous improvement methodologies (Lean Six Sigma). Six Sigma Black or Green Belt certification preferred.

Ability to prepare reports and present data to the Management team or key customers.

Perform contract reviews for new customers/products by reviewing purchase orders, specifications, and other customer requirements.

Minimum of 5 years experience in Quality Engineering/Quality Assurance

Report any and all issues immediately to upper management

Essential duties and responsibilities to include but not limited to:

Ensures that all cleaning & environmental monitoring practices are followed

Ensures that calibration of all equipment in the facility is maintained

Ensure routine preventive maintenance is completed on all equipment, INCLUDING the water system

Investigate all issues according to non-conformance procedure

Reviews product and process changes for qualification and validation requirements, and assists in change implementations

Understanding of drafting requirements per ANSI Y-14.5, including basic understanding of Geometric Dimensioning and Tolerancing

Strong attention to detail and good organizational skills

Proficient in computer technology including MS Office applications, with good analytical and problem-solving skills

Job Summary and Primary Responsibilities

Conduct investigations on complaints or audit issues.

Monitor and report to upper management on design control related projects.

Monitor and maintain DHF requirements in accordance with project timeline and design control requirements.

Mentors and coach colleagues/cross functional team members to share product and QMS/QA knowledge, and assist with training.

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Detail-oriented with a high sense of urgency, good organizational and time management skills

Product life-cycle management experience a plus

Implement and maintain a quality management program

Keep management team abreast of significant issues or developments identified during quality assurance activities and actions

Prepare and present technical and program information to the management team

Maintain a working knowledge of government and industry quality assurance codes and standards

Education, Licenses & Certification Requirements

Develop and manage supplier relationship (supplier qualification and supplier development)

3 - 5 years experience in a quality role

Set up and implementation of an advanced e-QMS system at a hands-on level (ETQ experience preferred)

Exhibit strong communication and problem-solving skills while leading the supplier toward company goals

Maintain and report on Quality Metrics (CARs, RMAs, COPQ, ECNs, PCNs, NCMRs, etc.)

Cucumber, Postman, SoapUI, TDD - Test Driven Development, Test Data Management, Zephyr

Candidate should have experience in mobile App testing and device testing in life science domain.

Programming skills to write test scripts in typescript/JavaScript and Appium.

Good knowledge in SQL queries and basic knowledge in writing stored procedure.

Knowledge in HP ALM, JIRA, Confluence, Browser stack is required.

Good to have knowledge in API testing, Web driver IO and mobile automation.

Essential functions of the position include, but are not limited to:

· Reviews purchase requisitions for compliance to quality control specifications.

· Designs and coordinates the development of specialized inspection tooling; proven out and develop related inspection procedures.

· Investigates instances of non-conformance and rejected material; develops corrective action and obtain customer or agency approval.

· Assist in the development of inspection training programs and in the train inspection personnel.

· Assists in maintaining division quality control manual; ensure that it is current with contact specifications.

Manages non-conforming materials, specifically RMAs and MRB cabinet, with Program Management, Production, and Quality from receipt to resolution

Defines and develops quality metrics in conjunction with Management

Manages and conducts internal audits

Assist and lead Qualification activities (IQ, OQ, PQ)

Basic knowledge and use of XRAY and AOI to aide and facilitate needed failure analysis to determine root cause

Other miscellaneous duties assigned by supervisor or manager to support manufacturing and operations

Act as Project Quality Manager and implement the Requirements of the Quality Management System on assigned projects.

Responsible for supporting improvement of supplier quality management of multiple manufacturing sites.

Assist with management and development of assigned Quality Engineers.

Knowledge of and experience with bug tracking systems.

Review project specific procedures and documents to verify that they comply with the contractual requirements.

Or modify and execute tests based on manual test cases, functional requirements or existing functionality of the system for product/project releases.

Support management of change process for all new projects for QC lab.

Analytical and problem-solving skills, Six Sigma or statistical experience preferred. Familiarity with Minitab or other tools preferred.

2 +years of experience in manufacturing / chemical industry or within the quality profession is required.

Ability to communicate effectively across all levels of the organization, and to manage cross functional teams is required.

Skilled in Microsoft Office suite.

SAP, and other database experience preferred.

Have strong follow up and time management skills.

Solid analytical and reasoning abilities as well as strong numerical skills.

Performs Customer Purchase Order/Contract Review to identify quality requirements for impact and operational compliance.

Pratt Whitney DQR/MCL-LCS / General Electric DSQR Qualification preferred.

Must possess strong problem-solving skills.

Excellent written and verbal communication skills

Strong technical writing and communication skills.

Work with other engineering functions for product design, development, verification, and validation.

Support the application of quality engineering/compliance of various functions and levels with technical responsibility or strategic input.

Identify and provide direction for statistical support in both design and routine manufacturing activities for achieving required levels of product reliability.

Lead the investigation, resolution, and prevention of product and process non-conformances.

Develop and conduct training when needed.

Informs and coaches production operators to undertake the quality standards in accordance with customer and or quality system requirements.

2 years of industrial experience preferred.

Competitive salary and benefits package

Excellent organizational skills, effective communication and ability to prioritize competing needs.

Understanding of quality systems ISO 9001/AS 9100 requirements.

Provide customers with technical support on testing issues and continuous improvements of quality systems.

Experience with bug tracking systems (GitHub Issues, Jira, Asana, etc.)

2+ years’ experience in a QA Engineer role testing interactive applications

Strong knowledge of QA methodology and tools

Good working knowledge of the differences between functional testing, regression testing, unit testing, performance testing and integration testing

One or more years of mobile testing/QA experience

Test desktop, AR/VR, mobile, and tablet websites, microsites, applications and software for performance, usability, appeal, and integrity