$67.40K - $87.10K/yr
Position Summary The Quality Engineer will support quality and compliance activities within a regulated Medical Device environment. This role is responsible for equipment (testing) validations, test ...
$67.40K - $87.10K/yr
Position Summary The Quality Engineer will support quality and compliance activities within a regulated Medical Device environment. This role is responsible for equipment (testing) validations, test ...
Quality Engineer
$64.30K - $83.10K/yr
We are seeking a Senior Quality Engineer to lead and strengthen our Quality Management System (QMS), ensuring ISO 9001 compliance, operational discipline, and continuous improvement across our ...
Quality Engineer
$64.30K - $83.10K/yr
We are seeking a Senior Quality Engineer to lead and strengthen our Quality Management System (QMS), ensuring ISO 9001 compliance, operational discipline, and continuous improvement across our ...
PR · On-site
$64.30K - $83.10K/yr
The Quality Engineer is responsible for improving product quality and ensuring efficient production operations. This position requires a strong background in mechanical engineering, process ...
Quick apply
PR · On-site
$64.30K - $83.10K/yr
The Quality Engineer is responsible for improving product quality and ensuring efficient production operations. This position requires a strong background in mechanical engineering, process ...
Quality Engineer
Barceloneta, PR · On-site
$54.30K - $109K/yr
Job Title Quality Engineer About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes ...
Quality Engineer
Barceloneta, PR · On-site
$54.30K - $109K/yr
Job Title Quality Engineer About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes ...
JT409 - QUALITY ENGINEER
Juncos, PR · On-site
$70.50K - $91K/yr
Collaborates with engineering and manufacturing functions to ensure quality standards are in place. * Devises and implements methods and procedures for inspecting, testing and evaluating the ...
JT409 - QUALITY ENGINEER
Juncos, PR · On-site
$70.50K - $91K/yr
Collaborates with engineering and manufacturing functions to ensure quality standards are in place. * Devises and implements methods and procedures for inspecting, testing and evaluating the ...
PR · On-site
$60.80K - $78.60K/yr
For Remediation services in the Quality Assurance area. WHAT MAKES YOU A FIT: The Technical Part: * Bachelor's Degree in Engineering and 5 years of experience in the review and approval of life cycle ...
Quality Engineer
Juncos, PR · On-site
$70.10K - $90.60K/yr
We are seeking a Quality Engineer to support validation activities within a regulated manufacturing environment, with strong involvement in process validation, equipment qualification, and quality ...
Quality Engineer
Juncos, PR · On-site
$70.10K - $90.60K/yr
We are seeking a Quality Engineer to support validation activities within a regulated manufacturing environment, with strong involvement in process validation, equipment qualification, and quality ...
Quality Engineer
Barceloneta, PR · On-site
$54.30K - $109K/yr
Job Title Quality Engineer About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes ...
Quality Engineer
Barceloneta, PR · On-site
$54.30K - $109K/yr
Job Title Quality Engineer About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes ...
Quality Engineer
$70.10K - $90.60K/yr
Collaborates with engineering and manufacturing functions to ensure quality standards are in place. * Devises and implements methods and procedures for inspecting, testing and evaluating the ...
New
Quick apply
Quality Engineer
$70.10K - $90.60K/yr
Collaborates with engineering and manufacturing functions to ensure quality standards are in place. * Devises and implements methods and procedures for inspecting, testing and evaluating the ...
New
PR · On-site
$64.30K - $83.10K/yr
Ensure compliance with Quality Control Standards, regulatoryrequirements,and company policies. * Document and report defects to Engineering Teamsand Managers. Requirements: * BSdegree in Electricalor ...
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PR · On-site
$64.30K - $83.10K/yr
Ensure compliance with Quality Control Standards, regulatoryrequirements,and company policies. * Document and report defects to Engineering Teamsand Managers. Requirements: * BSdegree in Electricalor ...
PR · On-site
$62.10K - $80.20K/yr
Lead external customer quality concern leading to trend analysis for project generation. Your background * Bachelor's Degree in Engineering; Mechanical or Electrical preferable. * Knowledge of ISO ...
Quality Engineer
Sabana Grande, PR · On-site
$50K - $70K/yr
Bachelor's degree in engineering. * 2 years of quality experience in a manufacturing environment- preferred. * Knowledge of Problem-Solving Tools (A3 and 8D) is required. * Knowledge of ISO/ IATF ...
Quality Engineer
Sabana Grande, PR · On-site
$50K - $70K/yr
Bachelor's degree in engineering. * 2 years of quality experience in a manufacturing environment- preferred. * Knowledge of Problem-Solving Tools (A3 and 8D) is required. * Knowledge of ISO/ IATF ...
Quality Engineer II
Humacao, PR · On-site
$72.90K - $94.20K/yr
The Quality Engineer II - New Product Introduction (NPI) is responsible for ensuring product and process quality throughout development, validation, process transfer, and production readiness for ...
Quality Engineer II
Humacao, PR · On-site
$72.90K - $94.20K/yr
The Quality Engineer II - New Product Introduction (NPI) is responsible for ensuring product and process quality throughout development, validation, process transfer, and production readiness for ...
Quality Engineer II
Humacao, PR · On-site
$72.90K - $94.20K/yr
The Quality Engineer II - New Product Introduction (NPI) is responsible for ensuring product and process quality throughout development, validation, process transfer, and production readiness for ...
Quality Engineer II
Humacao, PR · On-site
$72.90K - $94.20K/yr
The Quality Engineer II - New Product Introduction (NPI) is responsible for ensuring product and process quality throughout development, validation, process transfer, and production readiness for ...
Quality Engineer
Arecibo, PR · On-site
$62.10K - $80.20K/yr
Lead external customer quality concern leading to trend analysis for project generation. Your background * Bachelor's Degree in Engineering; Mechanical or Electrical preferable. * Knowledge of ISO ...
Quality Engineer
Arecibo, PR · On-site
$62.10K - $80.20K/yr
Lead external customer quality concern leading to trend analysis for project generation. Your background * Bachelor's Degree in Engineering; Mechanical or Electrical preferable. * Knowledge of ISO ...
Quality Engineer
Arecibo, PR · On-site
$62.10K - $80.20K/yr
Lead external customer quality concern leading to trend analysis for project generation. Your background * Bachelor's Degree in Engineering; Mechanical or Electrical preferable. * Knowledge of ISO ...
Quality Engineer
Arecibo, PR · On-site
$62.10K - $80.20K/yr
Lead external customer quality concern leading to trend analysis for project generation. Your background * Bachelor's Degree in Engineering; Mechanical or Electrical preferable. * Knowledge of ISO ...
Quality Engineer II
$72.90K - $94.20K/yr
The Quality Engineer II - New Product Introduction (NPI) is responsible for ensuring product and process quality throughout development, validation, process transfer, and production readiness for ...
Quality Engineer II
$72.90K - $94.20K/yr
The Quality Engineer II - New Product Introduction (NPI) is responsible for ensuring product and process quality throughout development, validation, process transfer, and production readiness for ...
Associate Quality Engineer
Barceloneta, PR · On-site
$45K - $89.80K/yr
Job Title Associate Quality Engineer About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating ...
Associate Quality Engineer
Barceloneta, PR · On-site
$45K - $89.80K/yr
Job Title Associate Quality Engineer About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating ...
Associate Quality Engineer
$45K - $89.80K/yr
Job Title Associate Quality Engineer About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating ...
Associate Quality Engineer
$45K - $89.80K/yr
Job Title Associate Quality Engineer About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating ...
$69.80K - $90.10K/yr
Ensure raw materials and finished products meet quality standards, improving processes, production output, and customer satisfaction. * Lead customer complaint management end to end, including ...
$69.80K - $90.10K/yr
Ensure raw materials and finished products meet quality standards, improving processes, production output, and customer satisfaction. * Lead customer complaint management end to end, including ...
Quality Engineer information
What Is a Quality Engineer?
A quality engineer ensures that the products manufactured by a company are meeting company and government quality control standards. As a quality engineer, your responsibilities include assessing and developing quality assurance protocols, examining products for compliance, and training teams to follow your policies. You also record data regarding production to track quality and produce the documentation need to communicate concerns throughout the company. The American Society for Quality (ASQ) regulates the profession and offers a path to become a certified quality engineer (CQE).
What are the key skills and qualifications needed to thrive as a Quality Engineer, and why are they important?
To thrive as a Quality Engineer, you need a solid grounding in engineering principles, quality assurance methodologies, and a relevant degree such as in engineering or a related field. Familiarity with tools like Six Sigma, ISO standards, statistical process control (SPC), and quality management systems (QMS) is typically required, and certifications like CQE (Certified Quality Engineer) are highly valued. Strong analytical thinking, attention to detail, and effective communication skills help you identify issues, collaborate with teams, and drive continuous improvement. These skills ensure that products and processes consistently meet standards, minimize defects, and enhance overall operational efficiency.
How does a Quality Engineer typically collaborate with other departments to ensure product quality?
Quality Engineers work closely with cross-functional teams such as manufacturing, design, and supply chain to uphold product standards. They often participate in team meetings, review process documentation, and coordinate root cause analyses with engineers and operators. Effective communication and proactive problem-solving are key, as they must ensure that quality requirements are clearly understood and implemented throughout each stage of production. This collaborative approach not only helps resolve issues quickly but also fosters a culture of continuous improvement across the organization.
What are Quality Engineers?
Quality Engineers are professionals who focus on ensuring that products or services meet consistent standards of quality. They develop and implement processes, conduct tests, and analyze data to identify areas for improvement in manufacturing or production. Quality Engineers often work closely with other departments to solve quality-related issues, maintain documentation, and ensure compliance with industry standards and regulations. Their goal is to minimize defects, reduce costs, and enhance customer satisfaction.
What is the difference between Quality Engineer vs Quality Technician?
| Aspect | Quality Engineer | Quality Technician |
|---|---|---|
| Responsibilities | Designing quality systems, process improvements, root cause analysis | Inspecting products, conducting tests, recording quality data |
| Required Skills | Analytical skills, problem-solving, knowledge of quality standards | Attention to detail, testing procedures, data collection |
| Certifications | ASQ CQE, Six Sigma | ASQ CQPA, basic quality certifications |
| Work Environment | Office, manufacturing plants, cross-functional teams | Manufacturing floors, labs, inspection stations |
Quality Engineers focus on developing and improving quality systems and processes, while Quality Technicians primarily perform inspections and tests to ensure product quality. Both roles are essential in maintaining standards, but they differ in scope and responsibilities.
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Job description
About Ultimate Solutions Corp.
Ultimate Solutions Corp. is a global leader in compliance and technology solutions, specializing in end-to-end integrated services for the Life Sciences industry. With over 20 years of experience, we have built core competencies by combining regulatory and quality expertise with advanced packaging automation, serialization, brand protection, and IT services. This unique blend of capabilities has enabled us to successfully support clients worldwide.
Position SummaryThe Quality Engineer will support quality and compliance activities within a regulated Medical Device environment. This role is responsible for equipment (testing) validations, test method validations, documentation review and approval, and support of quality investigations and CAPAs. The candidate will apply Quality Engineering principles and Six Sigma / Lean tools to drive continuous improvement and implement system or process modifications.
ResponsibilitiesExecute equipment (testing) validations in a Medical Device environment, including protocol development, execution, and final reports.
Perform and support test method validations to ensure compliance with intended use and regulatory requirements.
Support and/or lead quality investigations, including deviations, nonconformances, root cause analysis, and documentation.
Support the development, execution, and effectiveness verification of CAPAs.
Review, revise, and approve controlled documents (SOPs, protocols, reports, forms) in accordance with document control procedures.
Apply Quality Engineering principles and Six Sigma / Lean tools to design, evaluate, and implement system or process improvements.
Develop, implement, and maintain Sampling Plans based on risk and statistical rationale.
Support and execute Change Control activities, including impact assessments and cross-functional coordination.
Create, review, and maintain pFMEA documentation to identify, assess, and mitigate process risks.
Ensure compliance with GMP, ISO, and applicable regulatory requirements.
Bachelor's degree in Engineering or Sciences.
3-5 years of relevant experience in a regulated industry.
Required experience in the Medical Device or Pharmaceutical industry.
Strong knowledge and practical experience with GMP and ISO standards.
Strong computer skills, including proficiency with MS Office applications (Word, Excel, Outlook) and MS Project Management tools.
Solid knowledge of statistics, problem-solving methodologies, and Lean tools.
Ability to work effectively in a team-based environment.
Demonstrated ability to be a team player, self-starter, persistent, tactful, and persuasive.
Strong organizational skills, attention to detail, analytical thinking, and accuracy.
Effective verbal and written communication skills, including technical writing and presentations.
Ability to work with minimal or no supervision.
Fully bilingual in English and Spanish.
Ultimate Solutions Corp. is an Equal Opportunity Employer.
About Ultimate Solutions,Inc.
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