Quality Assurance Quality Control Engineer Jobs

Defect Management including logging defects, triaging severity and priority based on business input, and re-testing defect fixes

Design and execute test cases for features of a complex solution by understanding and analyzing functional and non-functional requirements

Bachelor's degree in IT related field or 3-5 years of experience in software testing

Strong communication, problem solving, self-organization, and teamwork skills

Experience with technologies and tools to support testing:

Experience with industry standard automated testing frameworks including TestCafe and Cypress

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.

Hadoop, Spark, and NoSQL. Experience

Job Title: QA Automation Engineer

Location: Tampa, FL, Irving, TX,

Some software quality experience strongly preferred

Proven experience as a Quality Engineer, ideally in medical device manufacturing

Strong analytical and problem-solving skills.

Assist in risk assessments, familiarity with ISO 14971 required

Support regulatory submissions from a quality standpoint

Assist in preparation for internal and external audits

Experience with test case management tools such as Test Rail

Exposure to defect/requirements management tools e.g. JIRA

Test case development based on functional and technical requirements

A minimum of 5-7+ years of experience in software development

Professional experience in agile/lean methodologies and processes - ideally Kanban or scrum as a minimum

Good communication skills both written and oral

**We will also considered candidates with 3+ years of specific Quality Experience no degree. Other Qualifications:

2+ years experience in a similar role / environment.

Experience in process improvement, supplier quality assurance, welding cells, destructive and non-destructive testing, and supervision are a plus.

Fundamental knowledge of calibration of measurement devices.

Leads investigation, & resolution of product and process non-conformance and helps determine corrective actions

Take part in continuous improvement initiatives, helps with problem solving and helps determine root cause analysis.

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

Bachelor's degree in mechanical or industrial engineering, production/operations management, or related technical field.

Plan, manage and report workload while proactively communicating foreseeable challenges.

Three to five years of experience in quality engineering in a manufacturing environment. Automotive experience is highly desirable.

Experience with ISO 9001 (experience with ISO 9001:2015, TS 16949, IATF 16949, or VDA is a plus).

Demonstrated knowledge of methodologies to ensure repeatability such as Cp, Cpk, Pp, & Ppk.

Demonstrated experience with Process Failure Mode & Effects Analysis (PFMEAs).

Job Title : Sr. Quality Control Inspector

Duration : Long Term Contract

Perform at-the-machine First Article Inspections for all multiple quantity precision fabricated parts

Determine and perform appropriate tests needed to verify fabrication has been performed as specified

Identify ongoing quality issues and make suggestions for improvement

Maintain and calibrate metrology equipment

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.

Advanced Knowledge of customer and ISO9001:2015 / IATF16949: 2016 requirements.

Possesses excellent verbal and written communication skills

Coordinate tasks/responsibilities to production personnel regarding Quality issues

Train and mentor quality and production personnel as required (Customer requirements, etc.)

Implement new procedures and processes in prototype stages of product launches in compliance with customer specific requirements

Post-secondary graduate with a degree/diploma in Quality Engineering and/or Mechanical/Automotive Engineering or equivalent work-related experience in the Quality field.

Participate in product design review with product managers, software engineers, and other stakeholders to contribute to product design, testability, and implementation.

5 years of experience working in a complex, matrixed & dynamic organization.

4 years of experience in Software development, coding, developing test automation using Python, or Java or C#.

3 years of experience in building and scaling test automation for web based applications using Javascript or Typescript.

4 years of experience in developing test methodologies, writing test plans, creating test cases, and debugging.

Experience with at least one automated test framework like Cypress, Playwright, or Selenium Webdriver.

Quality experience supporting high-volume automated manufacturing o Strong/extensive experience writing or approving nonconformances.

Supporting general operations quality function to support business needs for increased production.

Supports nonconformances, CAPA, and best practices, etc. for all production areas & general quality/compliance.

Full Benefits including Medical, Dental, Vision, Life Insurance

Perform various qualification and/or validation activities as required (may included APQP, IQ/OQ/PQ, PPAP, DOE, etc)

Company paid life insurance, short-term disability and long-term disability

Be certified or able get certified as an ISO-related internal auditor.

React to nonconforming product and customer complaints. Perform containment and work with other departments to determine root cause and corrective action.

Lead designated customer product through New Product review and release, including establishing production controls, performing risk assessment and manufacturing documents.

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.

Project management experience and ability to use Project Management software to plan, monitor and control activities.

Minimum of 5 years of engineering or manufacturing experience in a quality-oriented field.

Ability to manage and inspire a diverse cross-functional team working on simultaneous projects in a fast-paced environment.

Excellent computer literacy, including knowledge of shortcut keys.

Experience using OGP Vision Systems, QVI Zone3 Metrology software, or equivalent CMM technology.

Working knowledge of ISO9001, ISO13485, and U.S. FDA Code of Federal Regulations - (CFR) Title 21 is a plus.

Knowledge of quality systems, regulatory requirements, and industry standardsBlueprint reading and GD&T expertise

Offer quality support including inspection development, PFMEA, material issue resolution, and maintenance of quality documents.

Knowledge and ability to use appropriate measuring devices

3 + years of experience with quality assurance in manufacturing

Microsoft Platform with CAD experience

Analyze data and identify improvement opportunities based on samples

Experience with issue tracking and test management tools.

Bachelor's degree in Computer Science, Engineering, or a related field; relevant work experience may be considered.

Proven experience in software quality assurance, including creating and executing test plans, test cases, and test scripts.

Knowledge of programming languages, such as NodeJS, Python, or JavaScript, is a plus.

Excellent analytical and problem-solving skills, with the ability to identify and communicate issues effectively.

Effective communication skills, both written and verbal.

- Collaborate with cross-functional teams to understand project requirements and objectives.

- Perform security testing to identify vulnerabilities and ensure the software's security.

- Bachelor's degree in Computer Science, Information Technology, or a related field (or equivalent work experience).

- Proven experience in software quality assurance and testing.

- Strong analytical and problem-solving skills.

- Excellent communication and teamwork skills.

Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations.

0 - 3 years of manufacturing experience, or an equivalent combination of education and experience.

Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.

Feel stuck – we offer great opportunities to advance and learn

A quick learner who is always ready to gain depth of knowledge in manufacturing processes

Serves as a quality representative to assigned manufacturing areas and/or customers.