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Quality engineer jobs in Guaynabo, PR - 159 jobs

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  • CSV Manufacturing Engineer | Life Sciences & Med Device

    Mentor Technical Group 4.7company rating

    Quality engineer job in Caguas, PR

    A leading technical solutions provider is seeking an engineer specialized in the medical device industry. The role involves designing manufacturing processes and ensuring compliance with safety regulations. Candidates should have a BBA in Engineering, knowledge in CSV, and problem-solving skills (Yellow or Green Belt). The position offers an opportunity to work with innovative technologies in a dynamic environment located in Caguas, Puerto Rico. #J-18808-Ljbffr
    $58k-72k yearly est. 4d ago
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  • SAP Software Engineer - Data Conversions, Data Quality, and Reporting

    Cardinal Health 4.4company rating

    Quality engineer job in San Juan, PR

    **_What Application Development & Maintenance contributes to Cardinal Health_** Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value. Application Development & Maintenance performs configuration or coding to develop, enhance and sustain the organization's software systems in a cross-functional team environment through adherence to established design control processes and good engineering practices. This job family programs and configures end user applications, systems, databases and websites to achieve the organization's internal needs and externally-facing business needs. Application Development & Maintenance partners with business leaders, investigates user needs and conducts regular assessments, maintenance and enhancements of existing applications. The SAP Software Engineer focused on Data Conversions, Data Quality, and Reporting is responsible for designing, developing, and maintaining data solutions that ensure data integrity and enable effective business intelligence. The role combines technical skills in data migration and ETL processes with an understanding of data governance and reporting tools. **_What is expected of you and others at this level_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **_Responsibilities_** + Design and execute data conversion strategies for SAP implementations and upgrades, including data extraction, transformation, and loading (ETL) from legacy systems into SAP. + Utilize SAP data migration tools such as SAP Data Services, LSMW, and Migration Cockpit to perform data loads and conversions. + Develop and maintain technical specifications, data mapping documents, and transformation rules. + Collaborate with business and technical teams to gather data requirements and ensure seamless data flow across systems. + Establish and maintain data quality frameworks to ensure the accuracy, consistency, and integrity of master and transactional data in SAP. + Perform data profiling, cleansing, and validation to identify and resolve data discrepancies before and after migration. + Define and monitor data quality metrics and key performance indicators (KPIs). + Work with business data stewards to correct data quality issues and promote data governance policies and standards. + Design, develop, and implement reporting solutions, dashboards, and analytical models using SAP technologies like SAP Analytics Cloud (SAC), SAP BW/4HANA, or SAP Fiori. + Translate business needs into technical specifications for reports and ad-hoc queries. + Optimize report performance and data extraction processes for efficiency. + Provide support and training to end-users on reporting tools to enable data-driven decision-making **_Qualifications_** + Bachelor's Degree in related field preferred or equivalent work experience preferred + Proven experience in SAP Data Conversions, migrations and ETL processes. + Proficiency with SAP data tools such as SAP Data Services, SAP BW/HANA or SAP Analytics Cloud + Strong knowledge of SQL, data modelling and database concepts + Experience with SAP modules and data structures (e.g., Master Data, Financials, Supply Chain, OTC, PTP processes). + Excellent analytical, problem solving and communication skills + Ability to work both independently and collaboratively with cross-functional teams **Anticipated salary range:** $94,900 - $135,600 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 01/20/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************
    $94.9k-135.6k yearly 60d+ ago
  • Sr. Quality Systems Specialist - 132

    Flexible & Integrated Technical Services

    Quality engineer job in Juncos, PR

    For Engineer services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and three (3) years of exposure within the Pharmaceutical & Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Excellent Communication skills, and Positive attitude. Shift: 1st Shift Experience in: Process Validation and Computer Software Validation. Technical writing knowledge Organization and communication Investigation and Root Cause Analysis. The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analysis oversight continuing to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages. Coordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?
    $46k-52k yearly est. Auto-Apply 8d ago
  • Jt780 - Sr Quality Systems Specialist

    Quality Consulting Group

    Quality engineer job in Juncos, PR

    QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Coaches and reviews the work of lower level specialists Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Qualifications: Bachelor's degree in related area 4 years of relevant experience with Quality systems Investigation and root cause analysis skills Technical writing knowledge. Organization and Communication skills Process Validation and Computer software validation knowledge Availability for 1st shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
    $46k-52k yearly est. Auto-Apply 8d ago
  • Sr Quality Systems Specialist

    Mg Staffing Group

    Quality engineer job in Juncos, PR

    Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and\/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigation. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Other duties may be assigned. Requirements Minimum 4 years of relevant experience within the regulated industry. Experience in Investigation and root cause analysis. Knowledge in Process Validation, Computer System Validation and Technical Writing. Bilingual. Bachelor Degree in Engineering or Science Completed. Willing to work 100% on site and weekend or overtime when needed. "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Manufacturing"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Juncos"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Sr Quality Systems Specialist","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000015976001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26gCial6RtckyxSOPdzrQGXM\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}
    $46k-52k yearly est. 60d+ ago
  • Composites Supplier Quality Engineer

    GE Aerospace 4.8company rating

    Quality engineer job in San Juan, PR

    Are you ready to see your future take flight? At GE Aerospace, we are advancing aviation technologies for today and tomorrow. Your work will contribute to the production of advanced jet engines, components, and integrated systems that power commercial and military aircraft. You'll be part of a team that embraces your drive, your curiosity, and your unique ideas and perspectives. Most importantly, you'll share in our pride and purpose that affects the lives of millions around the world! In this role, the Supplier Quality Engineer for PMC & Raw Materials will drive quality for assigned suppliers, including quality plan implementation. Select suppliers through qualification processes. Own supplier results, drive improvements utilizing supplier scorecards. Own supplier audits, ensuring compliance, and driving improvement plans where needed. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. **Job Description** **Roles and Responsibilities** + Oversight and responsibility for supplier processes, from initial qualification, maintenance, and necessary improvements driven by Quality and Business needs. + Position includes regular supplier audits and system assessments for quality preparedness and process controls to remain adherent to GE process specifications and agency regulations. + Includes both Supplier Quality Assurance and Supplier Quality Development. Includes supplier qualifications, action plans, audits, performance monitoring, and assisting key suppliers towards industrial standards of excellence. SQEs have various levels of differentiation which are related to level of technical understanding of engineering drawings and ability to manage vendors. + Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. + A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. + Impacts projects, processes and procedures in own field. The role operates with some autonomy but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment but may require more senior levels of guidance. + Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. + **Travel fluctuates between 25% to 50% depending on the needs of the business** **Required Qualifications** + Bachelor's degree from an accredited university or college (or a high school diploma / GED with a minimum of 4 years of experience in Quality, Manufacturing, Shop Operations, Supply Chain Materials or Sourcing) + A minimum of 3 years' experience in Quality or Manufacturing Engineering **Desired Characteristics** + Strong communication skills. + Demonstrated ability to analyze and resolve problems. + Ability to document, plan, market, and execute programs. + Established project management skills. + Demonstrated experience working with Composites and/or raw materials + Demonstrated experience in manufacturing, supplier quality, statistical analysis, or customer quality + Demonstrated history of problem solving, root cause and corrective action methodology, data analysis and quality experience + Demonstrated experience in assembly, composites and/or systems engineering + Demonstrated, applicable, aerospace industry experience + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Focused: quick learner, strategically prioritizes work, committed + Leadership ability: strong communicator, decision-maker, collaborative + Problem solver: analytical-minded, challenges existing processes, critical thinker GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. The base pay range for this position is 90,000.00 - 110,000.00. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on **January 31st, 2026** . _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** No \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
    $55k-64k yearly est. 6d ago
  • Process Engineer

    Professional Skills Developers

    Quality engineer job in San Juan, PR

    Responsible for accessing the processes productivity challenges, generate and execute solutions following the procedures of and quality regulations of the client to assure improvement and sustainability of the results. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Assist process development activities. Performs root\-cause analysis, define and implement corrective\/preventive actions. Mitigate product failures at all stages of the client's manufacturing process. Identifies opportunities or the need for equipment, material or process changes or improvements. Provides product design reviews and feedback for manufacturability guidance. Responsible for developing process documentation and training materials for new processes, materials, and equipment process engineering and controls support. Requirements BS Degree in Engineering. One (1)) to five (5) years of work experience in a similar role. Strong customer service skills are necessary. \- Proven experience working with Six Sigma\/Process Excellence Tools and Methodologies (i.e. DMAIC, Lean Manufacturing, Process Mapping, Cause & Effect, FMEA, DOE) "}}],"is Mobile":false,"iframe":"true","job Type":"Contrato","apply Name":"Apply Now","zsoid":"664728484","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Biotecnologà a"},{"field Label":"Work Experience","uitype":2,"value":"1\-3 años"},{"field Label":"City","uitype":1,"value":"Isla"},{"field Label":"State\/Province","uitype":1,"value":"San Juan"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00936"}],"header Name":"Process Engineer","widget Id":"451563000000072311","is JobBoard":"false","user Id":"451563000000195003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"451563000002054422","FontSize":"12","google IndexUrl":"https:\/\/psdincpr.zohorecruit.com\/recruit\/ViewJob.na?digest=.AaMNETH9vCrdycgPVjmjgR1jtT5bfyqzaBW1rb2Ruw\-&embedsource=Google","location":"Isla","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do"}
    $70k-92k yearly est. 60d+ ago
  • Validation Engineer

    Pharmeng Technology Americas

    Quality engineer job in Guaynabo, PR

    Job Description As a global organization, PharmEng Technology has been providing quality services to leading manufacturers of the Pharmaceutical and Biotech industries since 1997. Our employees come from diverse backgrounds where we value unique talents and work together to support our clients. In addition, our consultants have extensive experience obtained from world-class organizations across the globe, and the development of our staff continues to grow PharmEng Technology. We are seeking an experienced Validation Engineer in Dorado, Puerto Rico. Objectives of this Role: Write and execute, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Summary Reports including thorough resolution of protocol discrepancies. Assess potential sources of variation in materials, processes, facilities, equipment, products, and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources. Maintain an up-to-date knowledge of validation requirements, practices, and procedures. Interpret existing Validation Plans and Project Plans and apply concepts to the task at hand. Working with a team to ensure all aspects of activity within the Process Development and Validation group adhere to required policies and procedures, including safety and training. Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results. Skills and Qualifications: • More than 5 years of experience in the industry (preferably with experience in medical devices). • Experience executing semi-automatic equipment validations (Debug, IQ/SQ, Process Characterization, OQ/PQ, etc.). • Technical knowledge. • Knowledge of software and/or PLC is an advantage. • The candidate must be committed to the project and work in person daily. Distance should not represent a risk of abandoning the project early. • Willing to work overtime or weekends if necessary. Our Benefits: Health, Dental, and Vision Insurance Benefits Training Opportunities and Career Development 401k plan with Employer Contributions PharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. PharmEng offers continuous career growth, competitive wages, travel opportunities, a team mentality that sets us apart from our competitors, and more!
    $49k-67k yearly est. 9d ago
  • Validation Engineer - Process Development

    Pharma-Bio Serv, Inc. 4.3company rating

    Quality engineer job in Dorado, PR

    Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide. Currently, one of our clients in the North Region is looking to hire a Validation Engineer - Process Development. Requirements: * BS Engineering with at least 3 years of medical devices or pharma experience. * Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products. * Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities. * Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures. * Design and develop in-process and receiving quality systems for new processes and components. * Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. * Define gages, tools and equipment for the test methods developed. * Generate manufacturing instructions for new processes being developed. * Work cross-functionally with other departments to accomplish PD tasks.
    $55k-75k yearly est. 60d+ ago
  • Manufacturing Engineer

    CIS International 4.6company rating

    Quality engineer job in Villalba, PR

    The Manufacturing Engineer is responsible for designing, developing, validating, and sustaining manufacturing processes, equipment, and systems to ensure efficient, compliant, and high-quality production. This role functions as an established individual contributor, supporting moderately complex projects and cross-functional initiatives within a regulated manufacturing environment. Key Responsibilities Responsibilities may include the following and other duties may be assigned: Design, develop, and optimize manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling. Design plant and equipment layouts to ensure efficient, safe, and productive manufacturing operations. Define sequences of operations and specify procedures for fabrication of tools, fixtures, and equipment impacting product performance. Adapt machine and equipment designs to meet factory and production conditions. Incorporate inspection and testing requirements into production and validation plans. Perform process and equipment performance evaluations to verify efficiency, capability, and compliance. Lead and support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA) to ensure product quality. Provide technical and sustaining engineering support to manufacturing operations. Develop and support manufacturing processes applicable to Statistical Process Control (SPC). Apply statistical techniques to analyze process performance and drive continuous improvement. Ensure manufacturing processes and procedures comply with applicable regulatory and quality requirements. Support and execute Process Validation, Equipment IQ, and Computer Software Validation activities. Provide technical guidance to design and engineering teams to ensure optimal use of equipment and manufacturing techniques. Participate in cross-functional meetings and project teams to meet operational and project objectives. Support project scheduling and execution to ensure deadlines are met without operational impact. May mentor or provide guidance to entry-level engineers or support personnel. Requirements: Education Bachelor's degree required in Engineering Minimum of 2 years of relevant manufacturing engineering experience in the regulated industry. Technical Knowledge & Skills Knowledge of Process Validation, Equipment IQ, and Computer Software Validation Experience conducting investigations and root cause analysis in manufacturing environments Knowledge of statistical techniques and Statistical Process Control (SPC) Ability to evaluate machinery, equipment, and tools to verify performance and efficiency Experience supporting technical and sustaining engineering activities Work Methodology: 100% On-Site in Villalba, PR Full time job Professional services job classification Administrative shift from Monday to Friday (8am-5pm) 6 months of 1st contract up to 2 years based on performance and budget
    $56k-67k yearly est. 25d ago
  • MF01-112425 PD Validation Engineer (Medical Devices)

    Validation & Engineering Group, Inc.

    Quality engineer job in Dorado, PR

    Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Engineer - Process Development Purpose Statement Engineer, Validations: Develops and reviews documentation and procedures, and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering. Key Responsibilities: Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products. Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities. Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures. Design and develop in-process and receiving quality systems for new processes and components. Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. Define gages, tools and equipment for the test methods developed. Generate manufacturing instructions for new processes being developed. Work cross-functionally with other departments to accomplish PD tasks. Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 3 - 5years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in medical devices operations. Must be fully bilingual (English / Spanish) with excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Strong knowledge (according to related area). Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.
    $49k-68k yearly est. 3d ago
  • Manufacturing Engineer (CSV)

    Mentor Technical Group 4.7company rating

    Quality engineer job in Caguas, PR

    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities Engineering Experience in Medical Device Industry Problem Solving Knowledge (Yellow or Green Belt knowledge) Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Qualifications Requirements/Knowledge/Education/Skills BBA in Engineering Knowledge in CSV Problem Solving Knowledge (Yellow or Green Belt knowledge) Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. #J-18808-Ljbffr
    $58k-72k yearly est. 4d ago
  • Principal Engineer, Industrial Engineering

    Cardinal Health 4.4company rating

    Quality engineer job in San Juan, PR

    **_What Industrial Engineering contributes to Cardinal Health_** Engineering is responsible for performing research and analyses to develop design options for components, products, systems and processes. Industrial Engineering is responsible for enhancing / developing processes, layout and associated tools. Identifies, analyzes and implements new or existing technology to optimize business processes. Designs process improvements to reduce cost, cycle time, improve quality and/or increase throughput. Directs external resources / contractors as required. The Principal Industrial Engineer supports Pharmaceutical Supply Chain Operations in the areas of capital project planning and management, capacity planning, operational process change, and overall distribution center operating layout optimization. The position will also support deployment of new process and automation solutions, facilitate new building designs and layouts changes. Additional responsibilities include partnering with Operations leaders, deploying capital project investments for Pharma Supply Chain Operations, and overseeing project implementation and adoption to realize improvements. **_Responsibilities_** + Drive process engineering initiatives including conceptual operational designs, layout-change scenarios, and innovative automation solutions. Work closely with business operations partners to iterate on solutioning to optimize results. Bring modernization concepts to Operations through material handling and engineering external partnerships. + Works closely with Pharmaceutical Supply Chain Operations Vice Presidents, and site leaders to manage capital projects planned within the buildings. Develops capital budget priorities, establishes preliminary budgets,business case justifications, and formalizes all capital requests for budgeted, approved, or newly scoped projects. + Leads multifunctional teams of stakeholders and contributors to deliver large complex projects on time and under budget.Coordinates with other functional groups including Corporate Real Estate,field operations, Security, Information Technology, Inventory, Quality & Regulatory, Sales,and EH&S to ensure efforts are aligned, and coordinated as projects are developed and analyzed. + Integrated team members supporting operations leadership teams to ensure that capital projects and infrastructure are deployed, coordinated, managed, and maintained to drive building performance expectations. This role also manages and executes small construction projects independent of Corporate Real Estate / Construction including all cage and vault construction resulting from expansion or relocation needs. **_Qualifications_** + Bachelor's Degree in related field or relevant work experience, preferred + 4-6 years of experience in Operations, project and budgetary management, capital investment analysis and deployment, leading complex projects with multi-functional teams, preferred + Experience with automation solutions, facility design, material handling systems, integrated warehouse controls and execution applications, preferred + Experience with AutoCAD and other software applications to drive warehouse design and concepting, preferred + Strong Leadership skills, Strong scheduling and organizational skills + Excellent technical problem-solving capability + High level of initiative - Team player + Willing and transparent communicator + Proficient with Microsoft Office Suite + Excellent written and verbal communication skills + Moderate travel to other facilities for projects and supervision of equipment installation (25%, up to 50% during specific deployment activities and project implementations) **_What is expected of you and others at this level_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **Anticipated salary range:** $94,900 - $135,600 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 3/13/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************
    $94.9k-135.6k yearly 17d ago
  • Nacelles Supplier Quality Engineer

    GE Aerospace 4.8company rating

    Quality engineer job in San Juan, PR

    Are you ready to see your future take flight? At GE Aerospace, we are advancing aviation technologies for today and tomorrow. Your work will contribute to the production of advanced jet engines, components, and integrated systems that power commercial and military aircraft. You'll be part of a team that embraces your drive, your curiosity, and your unique ideas and perspectives. Most importantly, you'll share in our pride and purpose that affects the lives of millions around the world! The Supplier Quality Engineer for Composites & Nacelles is an individual who can apply knowledge of RCCA and/or problem solving to lead supplier quality improvement of complex cross functional challenges. In this role, you will drive GE Aerospace quality standards for assigned suppliers, support customer disruption RCCA and Defect tracking, drive resolution to actions identified during problem solving, own supplier results, coordinate with customers on corrective action results from suppliers, and drive improvements utilizing supplier scorecards. In addition, you must demonstrate an in-depth understanding of key business drivers; use this understanding to accomplish their own work, as well have an in-depth understanding of how the work of their own team integrates with other teams and contributes to GE Aerospace, as a business. **Job Description** **Roles and Responsibilities** + Oversight and responsibility for supplier processes, from initial qualification, maintenance, and necessary improvements driven by Quality and Business needs. + Position includes regular supplier audits and system assessments for quality preparedness and process controls to remain adherent to GE process specifications and agency regulations. + Lead GE Aerospace supplier root cause and corrective actions to reduce systemic, product specific, and process related defects. + Requires specialized knowledge within the function. Influence the development of strategy for the area of responsibility, including control of resources and the influence of policy formulation. + Interpret internal and external business challenges and recommend best practices to improve products, processes, or services. Stays informed of industry trends that may inform work. + Uses high level of judgment to make decisions and handle complex tasks or problems in areas of operational, product management, manufacturing, technology, or engineering. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and can construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision. + May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on specific topics. May guide others to consider a different point of view. + Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions. + **Travel fluctuates between 25% to 50% depending on the needs of the business** **Required Qualifications** + Bachelor's Degree from an accredited college or university (or a high school diploma/GED with a minimum of 4 years quality engineering experience) + Minimum 3 years of experience in Quality or Manufacturing Engineering **Desired Characteristics** + **Demonstrated experience working with Nacelles** + Demonstrated experience in manufacturing, supplier quality, statistical analysis, or customer quality + Strong communication skills. + Demonstrated ability to analyze and resolve problems. + Ability to document, plan, market, and execute programs. Established project management skills. + Demonstrated history of problem solving, root cause and corrective action methodology, data analysis and quality experience + Demonstrated experience in assembly, composites and/or systems engineering + Demonstrated, applicable, aerospace industry experience + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Focused: quick learner, strategically prioritizes work, committed + Leadership ability: strong communicator, decision-maker, collaborative + Problem solver: analytical-minded, challenges existing processes, critical thinker GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. The base pay range for this position is 100,000.00 - 120,000.00. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on **January 31st, 2026** . _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** No \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
    $55k-64k yearly est. 6d ago
  • Process Engineer II

    Mg Staffing Group

    Quality engineer job in Villalba, PR

    Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and\/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. Other duties may be assigned. Responsible for developing, executing, and managing validation activities for utilities systems in compliance with regulatory requirements and internal quality standards. This role focuses on ensuring the qualification, performance, and reliability of critical utility systems, including but not limited to water systems, compressed air and HVAC. The ideal candidate will have experience in utilities validation and a thorough understanding of GMP regulations. Conduct utilities qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Requirements Minimum 5 years of experience in Utilities Equipment, Regulatory and Compliance Systems, Troubleshooting, Agile Systems, SAP Systems, Validation Qualification Phases and Commissioning. Bachelor or Technical Degree in Science or Engineering. Bilingual. Willing to work 100% on\-site in Villalba. What are the top 3 things you are looking for in a candidates experience: 1. Validation of facilities and utilities equipment including air compressor and HVAC system 2. FDA and ISO regulated industry experience 3. Operational SOP, validation protocols and maintenance plan "}}],"is Mobile":false,"iframe":"true","job Type":"Temporary","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Manufacturing"},{"field Label":"City","uitype":1,"value":"villalba"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00766"}],"header Name":"Process Engineer II","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000016593001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26iT6OuvU0tpqTzPsm4rsMQg\-&embedsource=Google","location":"villalba","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}
    $69k-91k yearly est. 60d+ ago
  • MV01-122325 Validation Engineer (Downstream Biologics)

    Validation & Engineering Group, Inc.

    Quality engineer job in Imbry, PR

    Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Engineer Project Duration: 4-6 months, with potential for extension or future projects at the site. Role Summary: We are seeking a self-sufficient Validation Engineer to support a downstream biologics validation project at a cGMP manufacturing site in Puerto Rico. The ideal candidate has hands-on experience validating downstream processes, equipment, and instruments and can manage validation activities with minimal supervision. Key Responsibilities: Execute and manage downstream validation activities (IQ/OQ/PQ, PPQ support). Validate downstream equipment including autoclaves, environmental chambers, chromatography, filtration/UF-DF, centrifuges, formulation systems, and lyophilizers. Validate analytical and process instruments (e.g., HPLC, in-line sensors). Author and execute validation protocols and reports in compliance with cGMP/FDA requirements. Collaborate with Engineering, Manufacturing, Quality, and Automation teams. Support deviations, change controls, and audit readiness as needed. Required Experience: Bachelor's degree in Engineering or Life Sciences. 5+ years validation experience in biologics/pharmaceutical manufacturing. Strong hands-on experience with downstream process and equipment validation. Ability to work on-site and operate independently. Excellent documentation and communication skills. Preferred: Prior support of commercial manufacturing or PPQ. Availability for project start within short notice.
    $49k-68k yearly est. 3d ago
  • Process Engineers (Validations)

    CIS International 4.6company rating

    Quality engineer job in Juncos, PR

    We are seeking candidates with a strong engineering background and hands-on experience in regulated manufacturing environments, preferably within the medical device industry. Ideal candidates will have direct experience with process validation activities including characterization, OQ, and PQ (non-cleaning), as well as equipment qualification such as URS, FAT, IQ, OQ, PQ, and TMV (non-laboratory equipment). Experience developing and executing validation strategies, flowing design requirements into manufacturing controls, and supporting design transfer activities is essential. Candidates should also be familiar with risk management tools such as pFMEA, possess basic statistical skills (Minitab preferred), and have participated in project-based validation work that demonstrates practical application of these concepts. Project: 6 new manufacturing lines for a medical devices company in Juncos-PR Responsibilities: This role is focused on building, validating, and enabling manufacturing processes. Generate and execute validation protocols. Perform process characterization activities. Manufacturing process development. Strong candidates will demonstrate a proactive, preventive mindset, with experience establishing process capability, supporting manufacturing readiness, and working closely with MS&T or Tech Ops functions. The emphasis for this position is on upfront process design, validation execution, and ensuring processes are robust, scalable, and production-ready. Requirements: Education: Bachelor´s degree in Engineering (Mechanical, Electrical, Chemical, etc.) 2 to 5 years of minimum experience Experienced with medical devices products Process Validation (PV): characterization, OQ, PQ (non-cleaning) Equipment Qualification (CSV): URS, FAT, IQ, OQ, PQ, TMV (non-lab) Validation strategies & requirements flow-down (design → manufacturing) Risk management documentation (pFMEA) Basic statistics (Minitab preferred) Design transfer activities Design requirements validation & manufacturing controls Project-based validation experience Work Methodology: Full time special project assignment Full on-site job in Juncos, PR 5 months of special project contract Shift: Administrative and wiling to support non-standard shifts based on project needs Availability to start this work on February 1st, 2026
    $68k-85k yearly est. 13d ago
  • Jt927 - Process Engineer I

    Quality Consulting Group

    Quality engineer job in Juncos, PR

    QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Generate, execute process validation plan and reports [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory) Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations. Qualifications: Bachelor's degree in Engineering 2+ years in validation experience Basic knowledge in defining validation strategies (e.g requirements flow down from design to manufacturing) Experience with Risk management documentation: pFMEAs Basic knowledge in statistics (preferably using Minitab) Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence) 1st Shift, 12 Hour Day Shift, 2nd Shift Availability to work extended shifts (8- 12 hours per shift) Availability to work weekends (Saturday and/or Sundays) Availability to work Holidays as require d Availability to work first and / or second shift (If require) mainly first shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
    $69k-91k yearly est. Auto-Apply 7d ago
  • Principal Validation Engineer

    Flexible & Integrated Technical Services

    Quality engineer job in Juncos, PR

    For CQV services in the Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with eight (8) years of experience as a C&Q Engineer within the pharmaceutical or regulated industry. Bilingual (English & Spanish). Project Management skills. Shift: Administrative, and according to business needs. Experience in: CQV Validation Expert: Risk-based qualification methods (ASTM E 2500) for pharmaceutical manufacturing equipment and utilities Sterilization & Cleaning Specialist (SME): CIP and SIP processes GMP Document Controller: Validation Protocols (IQ/OQ/PQ), Risk Assessments, and leading Root Cause Analysis (RCA) for quality issues. Engineering Project Support: P&IDs and FAT/SAT. The Personality Part: Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Review and/or Approve Lifecycle Documents, including but not limited to User Requirements, Risk Assessments, Data Integrity Assessments, Commissioning and Qualification Plans, Validation Plans, Installation, Operational and Performance Verification (included but not limited to Clean Utilities such as APR, WFI, SCL, and PW) protocols and reports Support field execution of commissioning/integration testing required by the C&Q Plan. Evaluate and approve protocol discrepancies/deviations with direct support in the Root Cause Analysis. Review engineering change notices and evaluate/propose modifications to the qualification strategies Participate in engineering design phases and propose strategies to assure successful qualification and start-up. Anticipate potential pitfalls based on regulatory /compliance guidance Apply Risk-Based Validation approaches based on Amgen Standard Operating Procedures and industry guidance Create and/or revise SIP drawings (~65) for Upstream and Downstream impacted circuits. Participate in project weekly meetings, such as Detail Design Technical Meeting and Slowdown Window Workshops for Upstream, Downstream, and Clean Utilities. Participate in risk assessments to identify potential hazards and implement appropriate controls, including, but not limited to, reviewing and approving the risk assessment report. Process and Equipment understanding, which includes P&IDs walkdown with engineering and determination of impacted circuits (product/non-product contact). Provide SME support to engineering phases, including basis of design, detailed design, risk assessments, and align the commissioning execution strategy with the CQ Service Provider (e.g., FAT, SAT, Set to Work, Safety, Maintenance, Receipt Verification, Installation Verifications, Functional Testing, etc) Clean In Place (CIP) expertise, which includes, but is not limited to, cycle development, cleaning studies, worst case determination, protocol, and report preparation. Steam In Place (SIP) expertise, including but not limited to Thermal, Biological Indicator, and Microbial Challenge testing to assess the effectiveness of the sterilization process and protocol, and report preparation. Evaluates and documents the commissioning and qualification impact to proposed critical system changes through the Change Control Program, if necessary. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the next piece?
    $49k-67k yearly est. Auto-Apply 58d ago
  • Composites Supplier Quality Engineer

    GE Aerospace 4.8company rating

    Quality engineer job in San Juan, PR

    Are you ready to see your future take flight? At GE Aerospace, we are advancing aviation technologies for today and tomorrow. Your work will contribute to the production of advanced jet engines, components, and integrated systems that power commercial and military aircraft. You'll be part of a team that embraces your drive, your curiosity, and your unique ideas and perspectives. Most importantly, you'll share in our pride and purpose that affects the lives of millions around the world! The Supplier Quality Engineer for CMC Coatings & Raw Materials is an individual who can apply knowledge of RCCA and/or problem solving to lead supplier quality improvement of complex cross functional challenges. In this role, you will drive GE Aerospace quality standards for assigned suppliers, support customer disruption RCCA and Defect tracking, drive resolution to actions identified during problem solving, own supplier results, coordinate with customers on corrective action results from suppliers, and drive improvements utilizing supplier scorecards. In addition, you must demonstrate an in-depth understanding of key business drivers; use this understanding to accomplish their own work, as well have an in-depth understanding of how the work of their own team integrates with other teams and contributes to GE Aerospace, as a business. **Job Description** **Roles and Responsibilities** + Oversight and responsibility for supplier processes, from initial qualification, maintenance, and necessary improvements driven by Quality and Business needs. + Position includes regular supplier audits and system assessments for quality preparedness and process controls to remain adherent to GE process specifications and agency regulations. + Lead GE Aerospace supplier root cause and corrective actions to reduce systemic, product specific, and process related defects. + Requires specialized knowledge within the function. Influence the development of strategy for the area of responsibility, including control of resources and the influence of policy formulation. + Interpret internal and external business challenges and recommend best practices to improve products, processes, or services. Stays informed of industry trends that may inform work. + Uses high level of judgment to make decisions and handle complex tasks or problems in areas of operational, product management, manufacturing, technology, or engineering. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and can construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision. + May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on specific topics. May guide others to consider a different point of view. + Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions. + **Travel fluctuates between 25% to 50% depending on the needs of the business** **Required Qualifications** + Bachelor's Degree from an accredited college or university in Engineering, Material Science or related fields (or a high school diploma/GED with a minimum of 4 years quality engineering experience) + Minimum of 3 years quality, coatings, or composites manufacturing experience **Desired Characteristics** + Demonstrated experience working with Composites, Composites Raw Materials, and/or Coatings + Demonstrated experience in manufacturing, supplier quality, statistical analysis, or customer quality + Strong communication skills. + Demonstrated ability to analyze and resolve problems. + Ability to document, plan, market, and execute programs. + Established project management skills. + Demonstrated history of problem solving, root cause and corrective action methodology, data analysis and quality experience + Demonstrated experience in assembly, composites and/or systems engineering + Demonstrated, applicable, aerospace industry experience + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Focused: quick learner, strategically prioritizes work, committed + Leadership ability: strong communicator, decision-maker, collaborative + Problem solver: analytical-minded, challenges existing processes, critical thinker GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. The base pay range for this position is 100,000.00 - 120,000.00. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on **January 31st, 2026** . _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** No \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
    $55k-64k yearly est. 6d ago

Learn more about quality engineer jobs

How much does a quality engineer earn in Guaynabo, PR?

The average quality engineer in Guaynabo, PR earns between $34,000 and $48,000 annually. This compares to the national average quality engineer range of $61,000 to $103,000.

Average quality engineer salary in Guaynabo, PR

$40,000

What are the biggest employers of Quality Engineers in Guaynabo, PR?

The biggest employers of Quality Engineers in Guaynabo, PR are:
  1. Professional Skills Developers
  2. Validation & Engineering Group
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