Quality Assurance Quality Control Engineer Jobs in Venango, Pennsylvania

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.

Full Benefits including Medical, Dental, Vision, Life Insurance

Excellent verbal/written communication skills are essential.

Technical degree (4 year) plus five years related experience; at least two years in electronics manufacturing is desirable.

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

Ability to analyze field failures and implement corrective/ preventive action to respond to customer complaints.

Assist in the analysis of quality costs.

You should also be aware of FMEA and how it integrates to the overall Risk management process.

You are expected to have several cycles or projects experience in working with Risk files or remediating risk files.

Good Communication skills and proactive behaviour expected.

Provide support to the overall Quality Management System (QMS) in support of customer requirements, company goals and quality initiatives.

Manage teams to facilitate Root Cause Analysis and drive product and process improvements.

Produce and deliver quality reports per contract requirements, working with production personnel, technical resources and subject matter experts as needed.

Meet with design and production engineering team to determine quality assurance parameters and implement requirements with production environment.

Develop training and documentation materials for production to enable the seamless knowledge transfer of manufacturing processes.

Member of the Failure Review Boards (FRB) representing the Quality Department for all Quality and reliability issues.

Provide support to the overall Quality Management System (QMS) in support of customer requirements, company goals and quality initiatives.

Manage teams to facilitate Root Cause Analysis and drive product and process improvements.

Produce and deliver quality reports per contract requirements, working with production personnel, technical resources and subject matter experts as needed.

Meet with design and production engineering team to determine quality assurance parameters and implement requirements with production environment.

Develop training and documentation materials for production to enable the seamless knowledge transfer of manufacturing processes.

Member of the Failure Review Boards (FRB) representing the Quality Department for all Quality and reliability issues.

Experience & Skills You’ll Need:

Document and proactively manage issues until resolution

Excellent interpersonal, communication and organizational skills are essential.

Experience in web and mobile apps testing;

Backend testing experience: API, Database (SQL)

Experience with project and bug-tracking systems like Jira;

In-depth knowledge of regulatory requirements and industry standards related to computer system validation.

Develop and execute computer system validation strategies and plans in accordance with regulatory requirements, industry standards, and company policies.

Support the validation plan, reviewing all necessary requirements for system data migration tasks and new system release efforts.

Review user requirements for current system software upgrades and new system user requirement specifications.

Ensure validation protocols meet user requirements, design configuration, and internal and industry regulatory requirements.

Review traceability matrix to ensure all requirements are linked to testing in order to determine functionality.

Strong Java and Selenium experience

Review and evaluate user needs and determine requirements

5+ years in an enterprise-level environment with automation testing

Expertise in supporting or testing cloud-based application, AWS, Azure

Lead or participate in complex initiatives on selected domains

Assure quality, security and compliance for supported systems and applications

Experience with requirements management tools and systems engineering concepts desired

Drives key quality requirements (e.g. Design for Test, Design for Reliability, etc.) in new product development.

Experience in New Product Development/ Medical Device Design required

Knowledge of ISO Quality System Standards desired

CQA, CQE, CSQE, or RAC certification desired

Excellent analytical decision making and problem-solving skills

Must have extensive experience with Root cause analysis

Must be skilled in Supplier Quality handling non-conformance materials and parts and can efficiently collaborate with suppliers for a swift resolution

Applicants for employment must be a U.S. Citizens due to government regulations and requirements

Ability to build strong supplier relationships and can provide proactive measures to ensure high standards, cost saving, and customer satisfaction

Must have a proven track record in non-conformance resolutions

Must be a shop quality expert and can excel in maintaining high standards and driving continuous improvements

4+ years of QA experience with Java, Selenium, & Cucumber

4+ years of experience building test automation frameworks from scratch

Comfortable working 2 days/week in office in downtown Pittsburgh

I'm looking for the following:

For finer details, apply today!

No C2C for this position please

The candidate needs to be local to Philadelphia due to the requirement of beingonsite three days a week.

The QA resource will be responsible for white box and black box testing of the WiFi Pass.

Black Box testing will be end-to-end (we already have test cases written for that).

onsite three days a week.

Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.

Exercises sound judgment and analytical in thought

Challenges status quo and initiates improvements

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.

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.