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MDR Quality Engineer Jobs in Mobile, Alabama

Quality Engineer Jobs
By The Effective Syndicate At Mobile, AL, United States
**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.
Quality Engineer Jobs
By Continental Motors, Inc. At , Mobile, 36615, Al
Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management.
Prepares and presents technical and program information to team members and management.
Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
Maintains a working knowledge of government and industry quality codes and standards.
Develops and initiates standards and methods for inspection, testing, and evaluation.
Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of the assigned product or component.
Quality Engineer Jobs
By Dream Team Partners At St. Clair County, AL, United States
Investigate and respond to customer concerns (HTR) including containment management, root cause analysis, and countermeasure validation.
Associate's degree (AA) or equivalent, or two years of related experience and/or training.
Strong language skills, including reading, analyzing, and interpreting complex documents.
Defect prevention analysis and addressing in-process defects.
Promote quality achievement and performance improvement.
Ensure product compliance with Customer Standards.
Quality Engineer Jobs
By SRG Global At , Covington, 30014
Quality expert in dimensional gauge design, evaluation, and certification
Experience working in a Quality function in a manufacturing environment
Experience working in the automotive industry
Who You Are (Basic Qualifications)
Develop quality planning process and documents
Customer liaison for 8D submittals, quality alerts and corrective action implementation and verification
Quality Engineer Jobs
By SWJ TECHNOLOGY At Vance, AL, United States
Strong knowledge and skills in statistics and/or QC tools inspections methods, CAD, GD&T and APQP.
Strong interpersonal and communication skills.
Ability to manage multiple priorities.
Three (3) years professional experience in Quality engineering, preferably in an automotive manufacturing field.
Basic skills in business economics and time and motion studies
Knowledge of OSHA and workplace health & safety programs
Quality Engineer Jobs
By DSJ Global At Georgia, United States
Support plant improvement efforts, as needed (e.g., improve QMS, documentation, problem solving capabilities)
Experience in ISO certified or regulated workplace a plus
Excellent problem-solving skills and ability to train others.
ASQ CQE or CMQ/OE certification or willingness to achieve certification
Facilitate statistical process method training for plant personnel; become an SME of the plant SPC system
Validate process and product changes to ensure desired results are achieved and sustainable
Quality Engineer Jobs
By Hanon Systems At Shorter, AL, United States
Basic metrology skills, Blue print reading and SPC knowledge
Basic quality system knowledge and system auditing experience or equivalent
College diploma in a technical field or suitable experience in quality disciplines
1-3 Years related automotive experience preferred or manufacturing / technical background
Proficient computer skills (Microsoft Word, Excel, PowerPoint)
Strong interpersonal skills & ability to work in a team environment
Quality Engineer Jobs
By Brightpath Associates LLC At Fort Payne, AL, United States
Meets expectation rating (rating score of 2 or 3) in all applicable Competencies as defined in the Performance Management Process
Must have 5 years of experience in manufacturing, (Automotive environment).
Ability to operate a CAD system (preferably CADKEY or Keycreator)
Ability to perform well in high pressure situations
Performance testing ( PPAP submissions)
Job Position : Quality Engineer
Quality Engineer Jobs
By Farasis Energy At Tuscaloosa, AL, United States
Excellent project management skills Proven experience in strategic planning and thinking.
2+ years of experience in quality engineering, quality assurance, or a similar role.
2+ years of experience in electric vehicle (EV) industry preferred
Experience coding and using QA software tools and processes.
Strong communication and interpersonal skills.
Strong analytical and problem-solving skills.
Quality Engineer Jobs
By PPG Industries At , Sylmar, Ca $85 an hour
Provide training to individuals whose work affects quality issues in the requirements of the QMS.
Experience in a manufacturing environment
Previous Experience with LEAN and Six Sigma methodology to evaluate risks is preferred.
Benefits will be discussed with you by your recruiter during the hiring process.
Responsible for implementing and maintaining business processes-FMEAs.
Develop and implement proactive Quality methodologies to transform the workspace from a reactionary organization to a proactive organization.
Quality Engineer Jobs
By Jobot At Huntsville, AL, United States
Customer support, customer trials, & other responsibilities.
BS or AS university or 6 years experience
3 min. Automotive Quality experience
Lead quality engineering, with teams with tasks for plant.
Leading problem solving, inspection/final inspection.
Running document updating including control plans, PFMEA, Process Flow, Gage planning.
Quality Engineer Jobs
By Paramit At Morgan Hill, CA, United States
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.
Quality Engineer Jobs
By Leaman Life Sciences At Alpharetta, GA, United States
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
Quality Engineer Jobs
By Better Therapeutics At San Francisco, CA, United States
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
Quality Engineer Jobs
By Revology Cars LLC At Orlando, FL, United States
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).
Quality Engineer Jobs
By Systems Ally At Pleasanton, CA, United States
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.
Quality Engineer Jobs
By Magna International At Ethridge, TN, United States
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.
Quality Engineer Jobs
By Select Source International At Austin, TX, United States
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.
Quality Engineer Jobs
By Route 92 Medical At San Mateo, CA, United States
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.
Quality Engineer Jobs
By Natech Plastics, Inc. At Ronkonkoma, NY, United States
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.
Quality Engineer Jobs
By Doherty | The Employment Experts At Faribault, MN, United States
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
Quality Engineer Jobs
By Avalign Technologies At Akron, OH, United States
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.
Quality Engineer Jobs
By Manufactured Assemblies Corp., LLC At Vandalia, OH, United States
Ensure processes comply with the Quality Management System
Complete process audits based on requirements of certifications and QMS
High computer competence, including MRP, MS Office, Database management
Bachelor’s degree in technical field preferred, or relative experience
Strong analytical, problem-solving, and decision-making, critical thinking, and leadership skills
Excellent verbal and written communication skills
Quality Engineer Jobs
By Veridian Tech Solutions, Inc. At Philadelphia, PA, United States
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.
Evergreen Requisition - Global Mdr Submission Analyst Ii - Remote
By Olympus Corporation of the Americas At United States
Assist Global MDR Submission Management in the successful identification and resolution of quality issues associated with complaints.
Bachelor of Science degree with a minimum of 1-3 years medical device experience
Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and 21CFR803.
Complaint Handling / Customer Service experience in the Medical Device / Pharmaceutical required.
Effective communication skills - both written and verbal English language.
Ability to effectively prioritize and manage workload.
Quality Engineer Jobs
By Access Genie At Lakewood, NJ, United States
We offer great benefits, including a 100% remote work environment, flexible schedules, and ongoing growth opportunities
Proven experience 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
Good analytical, critical thinking, and problem-solving skills
Communication skills and an ability to collaborate cross-functionally
Posses Quality Assurance certifications, such as CSTE, CSQA, or ISTQB
Quality Engineer Jobs
By Moseley Technical Services, Inc. At Canonsburg, PA, United States
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.
Quality Engineer Jobs
By Moseley Technical Services, Inc. At Charleroi, PA, United States
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.
Quality Engineer Jobs
By Maximustech Inc At North Haven, CT, United States
Familiar with Agile (Bill of Material & Drawing system) and BPCS (Materials management system).
Working knowledge of EU MDD (Medical Device Directive) and MDR (Medical Devices Regulation) requirements a plus
The Quality Engineer must be familiar with IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) documentation and execution.
Working knowledge of manual and automated/semi-automated equipment.
Excellent organization, Planning, Computer skills, Technical writing, Communication skills.MS Office Suite and Outlook.
Working knowledge of medical device manufacturing a plus

Are you looking for an exciting opportunity to use your Quality Engineering skills to help ensure the safety and reliability of medical devices? We are looking for a Quality Engineer to join our team and help us develop and maintain our medical device products. You will be responsible for ensuring that our products meet all applicable regulatory requirements and industry standards. You will also be involved in the development of new products and processes, as well as the improvement of existing ones. If you are passionate about quality and have a desire to make a difference in the medical device industry, then this is the job for you!

A MDR Quality Engineer is responsible for ensuring that medical devices meet the requirements of the Medical Device Regulation (MDR). The MDR Quality Engineer is responsible for developing and maintaining quality systems, performing audits, and ensuring compliance with applicable regulations and standards.

What is MDR Quality Engineer Job Skills Required?

• Knowledge of medical device regulations and standards
• Knowledge of quality management systems
• Ability to interpret and apply regulations and standards
• Ability to develop and maintain quality systems
• Ability to identify and resolve quality issues
• Ability to communicate effectively
• Ability to work independently and in a team environment

What is MDR Quality Engineer Job Qualifications?

• Bachelor’s degree in engineering, science, or related field
• 5+ years of experience in medical device quality engineering
• Certified Quality Engineer (CQE) or equivalent certification
• Knowledge of FDA Quality System Regulation (QSR) and ISO 13485

What is MDR Quality Engineer Job Knowledge?

• Knowledge of medical device regulations and standards
• Knowledge of quality management systems
• Knowledge of FDA Quality System Regulation (QSR) and ISO 13485

What is MDR Quality Engineer Job Experience?

• 5+ years of experience in medical device quality engineering
• Experience in developing and maintaining quality systems
• Experience in performing audits
• Experience in identifying and resolving quality issues

What is MDR Quality Engineer Job Responsibilities?

• Develop and maintain quality systems in accordance with applicable regulations and standards
• Perform audits to ensure compliance with applicable regulations and standards
• Identify and resolve quality issues
• Communicate effectively with internal and external stakeholders
• Work independently and in a team environment to ensure quality objectives are met