Quality Engineer Jobs in San Juan, PR

Requirements: Bachelor's Degree in Process and Quality Engineering, Industrial Engineering; in Management or Project Management, Quality Management, Business Administration, or related field. Minimum (6) six months of experience performing similar functions desirable. Mastery of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook) Excellent verbal and written communication skills in English and Spanish. Excellent customer service skills, abilities to work in a team and relate to people at all hierarchical levels. Excellent skills to transmit knowledge. Ability to achieve results with minimal supervision, to work under pressure, set priorities and work on multiple tasks simultaneously, meeting deadlines and with a sense of urgency. Ability to analyze data, processes and draw conclusions with attention to detail Good skills to conduct investigations and audits. Physical demands include when it is necessary to reach, push, pull and/or carry up to 20 pounds. Duties: Identify quality levels, ensuring that they are accurate, efficient, complete and in accordance with the criteria for a healthy operation, through the collection of documents, reports, and metrics. Generate reports of plans and progress status of the Projects, Compliance and Quality department. Carry out audits in accordance with the approved Annual Audit Plan, on the departments' compliance with their operational processes. Prepare and send reports to the Department of Health as required by administrative ordinances and to manufacturers, as required. Manage queries from leaders and employees on the establishment of practices and processes. Coordinate and participate in training activities such as "Train the Trainer" aimed at developing the members of the Efficiency Committee and/or designated employees. Manage table of manufacturer contracts with the required data and periodically send it to Management. Manage the records of manufacturer contracts, customer complaints and recalls of manufacturers that are worked on. Manage projects and register the assignment of the number of projects and other required information. Prepare projects in Microsoft Project (scope of the project, folder with the required information). Manage with clients the date of inspection by the Manager. Prepare closing documents, improvement surveys to share with the client by email after the project is finished. Follow up as required. Actively support cultural transformation processes. Employer with Equal Employment Opportunity.

The Quality Assurance Associate is responsible for the Quality Incoming sampling and physical inspection of raw materials and components in accordance with approved drawings and specifications and contributes in the maintenance of records on vendor performance. Performs evaluation of Device History Records for completeness and compliance to specifications during manufacturing processes and prior to final product release as needed. Performs usage decisions in SAP for Raw Materials, In-process and Finished Goods. Verify that line clearance is performed after manufacturing and packaging activities. Actively participates on the analysis and resolution of supplier quality problems. Ensures that work performed conforms to QSR, ISO and OSHA standards and regulations. **Job Description** We are **the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a **maker of possible** with us. The Quality Assurance Associate is responsible for the Quality Incoming sampling and physical inspection of raw materials and components in accordance with approved drawings and specifications and contributes in the maintenance of records on vendor performance. Performs evaluation of Device History Records for completeness and compliance to specifications during manufacturing processes and prior to final product release as needed. Performs usage decisions in SAP for Raw Materials, In-process and Finished Goods. Verify that line clearance is performed after manufacturing and packaging activities. Actively participates on the analysis and resolution of supplier quality problems. Ensures that work performed conforms to QSR, ISO and OSHA standards and regulations. **Responsibilities:** + Responsible for the inspection and timely disposition of raw materials and packaging components, following approved procedures and specifications. Documents inspection performed in SAP system and required forms in a timely manner. + Responsible for the timely disposition of In-Process material following approved procedures and specifications. Documents usage decision in SAP. Ensures that all testing and documentation of manufacturing data is complete and accurate. + Responsible for the timely disposition of Finished Goods following approved procedures and specifications. Documents product disposition in SAP. Ensures that all testing and documentation of manufacturing data is complete and accurate. + Assures that Quality Notifications for non-conforming materials are created, investigated, completed and closed in accordance to the established Standard Operating Procedures. + Evaluate that line clearances are performed in a timely and effective manner per establish standard operating procedures. + Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management. + Promotes a safe environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety (EH&S) programs. Address corrective actions whenever a hazard is identified. + Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability. + Performs other related duties and assignments as required. **Minimum Requirement:** + Associate Degree with five years of Quality Assurance experience in a pharmaceutical/medical device environment. + Preferred a Bachelor Degree in a related scientific discipline (such as Chemistry, Biochemistry, Microbiology, Biology, and Engineering) and a minimum of one (1) year of quality assurance/regulatory affairs experience in a pharmaceutical/medical device environment or equivalent combination of related education and experience. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. **Why Join Us?** A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. \#earlycareer Required Skills Optional Skills . **Primary Work Location** USA PR Cayey - Vicks Drive (BDB) **Additional Locations** **Work Shift** US BD 2nd Shift 230pm-11pm (United States of America) Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Join our dynamic team and be part of shaping the future! Build knowledge and support the team, participate in problem solving discussions. Let's embark on this exciting journey together! Job Description * This candidate will be responsible for prioritizing, reviewing, and delivering First Article Inspections (FAI's) for sustaining parts and development projects * The candidate will be responsible to perform First Article Inspection (FAI) assessments per AS9102 for verification of customer/client requirements * The role will require metrics tracking on a continual basis to meet the increasing FAI load throughout the year * Develop and operate quality management systems to drive quality excellence and business performance * Manage process improvement efforts using quality methodologies and principles * Provide operational excellence practices and training * Identify and assess enterprise risks, developing an integrated approach to actively manage those risks * Analyze designated performance measures and reports to ensure work is consistently and effectively performed Job Requirements * Must be a United States Citizen Qualification Basic Qualifications * Associate's Degree in Science and/or Engineering OR minimum of 6 months experience in Manufacturing and/or Engineering * Minimum of 1 year experience with MS Office Suite to include Excel and Outlook Preferred Qualifications * Ability to understand and interpret cad or engineering drawings * Experience with Net Inspect * Familiarity with AS9102 forms 1, 2, 3 * Aerospace and Defense industry experience Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired in California, Colorado, District of Columbia, Illinois, Maryland, Minnesota, New York or Washington as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. Role Location Hourly Salary Range California $19.71 to $38.51 Colorado $19.71 to $33.27 District of Columbia $21.01 to $35.43 Illinois $18.27 to $33.27 Minnesota $19.71 to $33.27 Maryland $18.27 to $30.82 New York $18.27 to $38.51 Washington $21.01 to $35.43 Locations

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. 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 precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS AUTONOMY: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. Must have: • Performed and/or reviewed process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) • Knowledge in Med Devices regulations • Experience working and executing Design transfer activities • Experience with implementation of new products: design requirements validation, manufacturing controls • Experience with Risk management documentation: pFMEAs • Basic knowledge in statistics • Basic knowledge in designing validation strategies

**Your Future Evolves Here** Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and primary care, we seek to connect the pieces of fragmented health care system and ensure people get the same level of care and compassion we would want for our loved ones. Evolent employees enjoy work/life balance, the flexibility to suit their work to their lives, and autonomy they need to get things done. We believe that people do their best work when they're supported to live their best lives, and when they feel welcome to bring their whole selves to work. That's one reason why diversity and inclusion are core to our business. Join Evolent for the mission. Stay for the culture. **What You'll Be Doing:** **Site Reliability Engineer** As a member of the Platform Engineering organization, you will be part of a team responsible for managing the large footprint of our application suite and cloud infrastructure. **It is important to know ...** We are transforming the way we manage cloud infrastructure and application reliability, your role as Site Reliability Engineer is instrumental in our success. This role is for you If you are interested in becoming part of our high-performance team. **What you'll be doing ...** + Implement and manage observability solutions using **OpenTelemetry** to monitor and trace application performance. + Implementing and managing containerization solutions using platforms such as **Docker** and **Kubernetes** , with a strong focus on **Azure Kubernetes Service (AKS)** and **Azure Container Apps (ACA** ). + Monitor the health and performance of containers and resolve any issues that arise. + Follow security best practice to ensure containerized workloads are fully secure. + Partner with DevOps in advancing **Infra as Code** and Config as Code discipline. + Partner with Platform Architecture team to continuously improve Internal Developer Platform (IDP). + Participate in Root Cause Analysis (RCA) to identify corrective action plan (CAP). **Required and Preferred Experience:** + 3+ years of hands-on **Azure** and 5+ years of overall cloud-native experience. + Strong understanding of **OpenTelemetry** and experience in implementing observability solutions. + Proven experience in implementing and managing container orchestration platforms such as **Kubernetes and Docker.** + Deep understanding of deployment methodologies for Kubernetes, preferably **ArgoCD** and **Helm** . + Experience with other Azure services such as **Azure Functions** , **Azure Logic Apps** , and **Azure Service Fabric** . + Passion and creativity for Automation using tools such as **Ansible** and **Terraform** . + Experience in working with **GitHub** Actions or Jenkins. + Expertise in at least one of these **scripting/configuration** languages: PowerShell, YAML, HCL, Python. + Expertise in at least one of the APM tools: Prometheus, Dynatrace, **DataDog** . + Experience leveraging **agile** methodology (i.e., Scrumban) to manage project work. + Highly **effective communicator** with a strong commitment to transparency. + **PostGresSQL** and **Fast Healthcare Interoperability Resources (FHIR API)** experience is preferred. \#LI-DNI **Technical Requirements:** We require that all employees have the following technical capability at their home: High speed internet over 10 Mbps and, specifically for all call center employees, the ability to plug in directly to the home internet router. These at-home technical requirements are subject to change with any scheduled re-opening of our office locations. **Evolent is an equal opportunity employer and considers all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.** **If you need reasonable accommodation to access the information provided on this website, please contact** ************************** **for further assistance.** The expected base salary/wage range for this position is $120,000 - 135,000. This position is also eligible for a bonus component that would be dependent on pre-defined performance factors. As part of our total compensation package, Evolent is proud to offer comprehensive benefits (including health insurance benefits) to qualifying employees. All compensation determinations are based on the skills and experience required for the position and commensurate with experience of selected individuals, which may vary above and below the stated amounts. Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!

We are building the next-generation IaaS cloud and cloud support experience to go with it. Our teammates are skilled, customer-focused site reliability engineers building a world-first and outstanding customer experience blending sys admin, database engineering, and cloud subject areas. You'll be part of a team that learns deeply how our cloud platform works so you can be the bridge between Engineering and Operations. As part of the broader Engineering organization, you will act as the voice of the customer to influence product features and plans to improve customer experience. This role is integral to the success of our customer relationships and is critical to the success of the platform. This role will support Oracle's Government customers and solve sophisticated problems related to infrastructure cloud services and build automation to prevent problem recurrence. Design, write, and deploy software to improve the availability, scalability, and efficiency of Oracle products and services. Design and develop designs, architectures, standards, and methods for large-scale distributed systems. Facilitate service capacity planning and demand forecasting, software performance analysis, and system tuning. \#LI-ES2 Career Level - IC4 **Responsibilities** Identifies and implements sophisticated solutions to knowledge of server hardware and software configuration, networking, standard internet services, scripting languages, cloud computing patterns, technology security and compliance on large scale customer facing web services. Identifies and implements complex solutions to understanding of load balancing technologies and experience with development in programming languages, databases and big data stores, and container technologies. Work involves defining and documenting technical architecture of complex and highly scalable products. A BS or MS in Computer Science, or equivalent. Identifies and implements complex solutions to knowledge of server hardware and software configuration, networking, standard internet services, scripting languages, cloud computing patterns, technology security and compliance. Experience running large scale customer facing web services. Identifies and implements complex solutions to understanding of load balancing technologies and experience with development in programming languages, databases and big data stores, and container technologies. Work involves defining and documenting technical architecture of complex and highly scalable products. A minimum of 8+ years experience of running large scale customer facing web services. **Responsibilities:** + Act as a point of escalation for incidents and other issues arising within the region, for the cloud database services. + Operates and performs maintenance to cloud database services running within the region. + Deploys code and executes other changes within the region. + Ensures thorough documentation of incidents through company-standard reporting methods. + Act as customer champion and translate customer needs to technical requirements or enhancements to the cloud database services. + Drives and actively participates in the resolution of complex technical issues spanning various services. **Requirements:** + **US Citizenship AND Possess and Maintain US Government TS/SCI w/Poly Security Clearance Required.** + Bachelor's degree, in Computer Science, MIS or other technical field, or equivalent work experience. + A minimum of 8+ years' experience with large scale customer facing web services. + Solid experience with Linux. + Experience troubleshooting complex software and/or networking issues. + Solid understanding of cloud concepts and platforms. + Experience in cloud technical support, operations, NOC or similar is preferred, but not required. + Experience working with government customers is preferred, but not required. + Confirmed ability to quickly learn new technical domains and then train others. + Great verbal and written communication skills. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range: from $97,400 to $199,500 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's problems. True innovation starts with diverse perspectives and various abilities and backgrounds. When everyone's voice is heard, we're inspired to go beyond what's been done before. It's why we're committed to expanding our inclusive workforce that promotes diverse insights and perspectives. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer a highly competitive suite of employee benefits designed on the principles of parity and consistency. We put our people first with flexible medical, life insurance and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by calling ***************, option one. **Disclaimer:** Oracle is an Equal Employment Opportunity Employer*. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law. *** Which includes being a United States Affirmative Action Employer**

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. JOB SUMMARY To enhance the capabilities of the QA Department by providing administrative and technical support to the Quality Engineer. ESSENTIAL DUTIES AND RESPONSIBILITIES * Prepare visual aids. * Prepare calibration tracking list and tracking to ensure all equipment that needs calibrated is done. * Assist the Quality Engineer or Quality Technician in the engineering function. * Prepare the raw data for analysis. * Help to do the routine process and product audit. * Help to create the machine program. * To follow up the new product introduction and experiment. * To monitor the SPC status of related area. * To review the defect sample and check the purge process. * Help to setup MES for new products. * To follow up the execution of DA,ECN and CAPA (Corrective Action and Preventive Action). * To review non-conformance material and products. * May perform other duties and responsibilities as assigned. JOB QUALIFICATIONS KNOWLEDGE REQUIREMENTS * Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. * Ability to define problems, collect data, establish facts, and draw valid conclusions. * Ability to operate a personal computer including using a Windows based operating system and related software. * Advanced PC skills, including training and knowledge of Jabil's software packages. * Ability to write simple correspondence. Read and understand visual aid. * Ability to apply common sense understanding to carry out simple one- or two-step instructions. * Ability to deal with standardized situations with only occasional or no variables. * Ability to read and comprehend simple instructions, short correspondence, and memos. * Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. * Ability to compute rate, ratio, and percent and to draw and interpret graphs. BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver's license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (************* the Federal Trade Commission identity theft hotline (********************** and/or your local police department. Any scam job listings should be reported to whatever website it was posted in. Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law. Accessibility Accommodation If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_******************** or calling ************ with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

Johnson & Johnson is recruiting for a Sr Quality Engineer for Shockwave Medical Inc. located in United States. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ********************* For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. Description Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Description Position Overview: The Sr. Quality Engineer will support manufacturing and work cross-functionally to resolve technical problems. Participates in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Provides and develops solutions to broad problems, accomplishes complex assignments, develops protocols for design, and/or process activities, (including those related to verification or validation activities), determines criteria and subsequently generates summary (or final) reports. Essential Job Functions: + Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products. + Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment. + Prepares documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, and product defect investigations. Must be able to write a technical document with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence. Must be able to review and provide value-added feedback to others writing such documents. + Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments. + Provides guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices. + Independently performs most assignments with an understanding of the overall expectations. Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. + Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project. + Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements. + Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset. + Independently assesses if components, sub-assemblies, products meet specification and can initiate, investigate and resolve non-conformances by working in conjunction with a multidisciplinary team. + Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. + May participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes, and ensure the process has adequate and appropriate process controls. May be responsible for participating and/or taking lead role in developing the risk management plan for new projects transitioning into manufacturing. (Hazard assessment, design trace matrix development, DV&V testing, and FMEA). + May technically supervise or coordinate the work of engineers, technicians, and others who assist in specific assignments. + May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would be an asset. Familiarity with IEC 60601 and IEC 62304 is an asset. + Processing, investigating, and completing customer complaints, which could require direct email responses to customers. + Composes technical complaint reports timely and accurately based on reported information and device investigation data. + Responsible for developing and maintaining calibration requirements for tools and equipment in the R&D, Manufacturing, and Quality areas. + Knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications would be a great asset. + Other duties as assigned. **Qualifications** Requirements: + BS in a related engineering discipline and 5+ years of related experience; or MS in a related engineering discipline and 3+ years of related experience + Experience in the medical device industry is highly preferred + Strong technical writing skills are required + Experience in customer complaint investigations and complaint report writing + Experience in manufacturing support as a Quality Engineer + Must be proactive, self-motivated, and work independently with minimal supervision + Experience with balloon catheters and electrical systems is strongly preferred + Experience in completing Medical Device Reports (MDR) and Vigilance (MDV) submissions is an asset + Experience in writing and reviewing design verification and validation protocols + Preferred experience in generating documentation and criteria for validation of manufacturing line transfer to alternative sites + Certified Quality Engineer would be an asset + Must be willing to travel up to 10% of the time + Effective communication skills with all levels of management and organizations + Operate independently and adaptability to changing requirements + Ability to work in a fast-paced environment, managing multiple priorities The anticipated base pay range for this position is $89,000 to $142,600. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. + Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. + Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). + Employees are eligible for the following time off benefits: + Vacation - up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year + Holiday pay, including Floating Holidays - up to 13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on January, 8, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ********************

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Job Title Associate Manufacturing 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 in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: * Career development with an international company where you can grow the career you dream of. * Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days. * A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. * A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Arecibo, PR location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. The Associate Manufacturing Engineer will serve as the primary engineering personnel supporting manufacturing operations in CRM. The individual performing this role will have to create a strong teamwork with the line supervisor, Quality Engineer and operators to address all the opportunities found in the assigned manufacturing line. He/She will be accountable on quality, safety, output and yield of the assigned manufacturing line. He/She will serve as the engineering management representative in the manufacturing line, executing initiatives and working directly with the DL workforce. This person may also have a role beyond the line support engineering as a sustaining engineer for the department. What You'll Do * Responsible for assigned line output, safety, yield and quality. Responsible for identification of product defects and determination of operational and process related actions to reduce the defects. This may also include equipment troubleshooting and sub-sequent work order request. * Works with line support team (QC Supervisor, Mfg. Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance is present, determine initial bracketing and containment, and support generation of ER, if needed. * Responsible for product/process knowledge and understanding of basic cause and effect of line and process changes. * Responsible for providing the line with related Engineering fixes, such as tooling (TLTs) and Manufacturing Aids (from idea definition to implementation) * Support maintenance technicians and supervisors in equipment availability issues. Review equipment work order completion and performs product impact analysis in order to release equipment for commercial manufacturing use. * Supports Training and Certification Program. * Responsible for determining quality impact of Out-of-Tolerance documents. * Responsible for execution of line related change management (material, equipment and process changes). Responsible for CO and simple CR generation related to changes impacting the manufacturing line. * Responsible for simple continuous improvement projects development and execution. * Responsible for exception subtask execution. * Evaluates ideas from the LPI program for potential implementation. * Leads root cause analysis efforts for basic/simple manufacturing events, utilizing DMAIC model and A3s. Supports CAPA (Major) investigations with data gathering and analysis as needed. * Runs studies and validations on the line as needed. Writes protocols and reports with oversight. * Line support representative for related projects such as yield improvements, CIP's, productivity, quality and safety. * Responsible for coordination of product builds through the NPI process. * Generates simple changes to the eLHR system. * Demonstrates basic understanding of regulations (Compliance and EHS) for work area. Provides recommendations for improvement and executes as needed. May initiate, investigate and/or approve CAPA records. * Supports EHS and/or Reg Compliance audits. Required Qualifications * B.S. in engineering discipline. * Basic knowledge of applicable US and non-US applicable regulations. * Knowledge and proficiency in the application and principles of Manufacturing/Process * Engineering. * Ability to effectively communicate cross-functionally to assist with resolving * Quality/Engineering issues. * Excellent written, verbal and interpersonal communication skills in both English and * Spanish * Knowledge of common office applications: Word, PowerPoint, Excel. * Ability to interact effectively with all levels of employees. Preferred Qualifications * Desirable: Basic Statistics Knowledge Apply Now Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $44,700.00 - $89,300.00. In specific locations, the pay range may vary from the range posted.

**_What Supplier Quality contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing supplier's quality management system to applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues. **Responsibilities** + Adhere to Good Manufacturing Principles (GMPs) based Quality Management Systems requirements for medical devices and medicinal products + Identify and lead implementation of preventive and corrective actions via CAPAs, audits, NCMRs, and complaint handling systems + Lead implementation of Supplier Change Requests and utilize Production Part Approval Process (PPAP) + Key contributor on NPD (New Product Development) projects, ensuring rigorous performance and APQP deliverables (CTQ, PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, PPA, etc.), in collaboration with Procurement, Manufacturing and R&D + Ensure supplier quality systems adhere to all applicable regulations and standards + Ability to lead and influence cross-functional teams to drive reduction in patient safety risk and greater levels of regulatory compliance + Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance **Qualifications** + 4-8 years of experience, preferred + Bachelor's degree in related field, or equivalent work experience, preferred **_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** : $79,700 - $113,800 **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: 1/20/2025 *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. \#LI-MP1 _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 (***************************************************************************************************************************

When you join Renaissance , you join a global leader in pre-K-12 education technology! Renaissance's solutions help educators analyze, customize, and plan personalized learning paths for students, allowing time for what matters-creating energizing learning experiences in the classroom. Our fiercely passionate employees and educational partners have helped drive phenomenal student growth, with Renaissance solutions being used in over one-third of US schools and in more than 100 countries worldwide. Every day, we are connected to our mission by exemplifying our values: trust each other, win together, strive for the best, own our actions, and grow and evolve. Site Reliability Engineers are members of our Site Reliability Operations team. Site Reliability Engineers design, implement, and monitor tooling, systems and infrastructure that support our customer-facing SaaS applications spanning several virtual and cloud environments, worldwide. Site Reliability Engineers also ensure success in areas including incident management, successful deployment of application code and data integrity. Essential Functions and Responsibilities: + Monitor and investigate issues in cloud environments + Operate and maintain monitoring systems and frameworks in multiple environments + Deploy code in multiple environments + Assist with writing/modifying new/existing scripts and infrastructure code + Enhance and support automated CI/CD pipelines + Infrastructure capacity planning + Troubleshoot and communicate during production outages and performance events + Provide off-hours and emergency support through on-call rotation + Contribute to disaster recovery exercises + 1-2 years of DevOps, Site Reliability, Operations, or Software Development experience + Experience with or well-rounded knowledge of key cloud best practices, tools, techniques, and frameworks + Experience working with programming/scripting languages, infrastructure as code, deployment, and monitoring tools and methodologies + A sound understanding of application monitoring and troubleshooting + Ability to perform code deployments in multiple environments with a variety of tools + Basic knowledge of infrastructure as code principles + Experience with AWS - Amazon Web Services. _Bonus if you have:_ + AWS certifications + Experience with: + Jenkins + New Relic + Python + GitHub Actions + FinOps All your information will be kept confidential according to EEO guidelines. **Salary Range: $61,000-$80,000** + This range is based on national market data and may vary by experience and location. **Benefits for eligible employees include:** + World Class Health Benefits: Medical, Prescription, Dental, Vision, Telehealth + Health Savings and Flexible Spending Accounts + 401(k) and Roth 401(k) with company match + Paid Vacation and Sick Time Off + 12 Paid Holidays + Parental Leave (20 total weeks with 14 weeks paid) & Milk Stork program + Tuition Reimbursement + Life & Disability Insurance + Well-being and Employee Assistance Programs Frequently cited statistics show that some women, underrepresented individuals, protected veterans and individuals with disabilities may only apply to roles if they meet 100% of the qualifications. At Renaissance, we encourage all applications! Roles evolve over time, especially with innovation, and you may be just the person we need for the future! EQUAL OPPORTUNITY EMPLOYER Renaissance is an equal opportunity employer and does not discriminate with respect to any term, condition or privilege of employment based on race, color, religion, sex, sexual orientation, gender identity or expression, age, disability, military or veteran status, marital status, or status of an individual in any group or class protected by applicable federal, state, or local law. REASONABLE ACCOMMODATIONS Renaissance also provides reasonable accommodations for qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local laws. If accommodation is needed to participate in the job application or interview process, please contact Talent Acquisition (TATeam@renlearn CRM.onmicrosoft.com) . EMPLOYMENT AUTHORIZATION Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or take over sponsorship of an employment Visa at this time. For information about Renaissance, visit: ****************************

GENERAL DESCRIPTION: Coordinates appointments and services, and supports all initiatives related to quality documents. Provides support to the entire Quality Department by preparing documents and reviewing information to comply with the different regulations and policies and procedures. ESSENTIAL FUNCTIONS: Performs data entry, and review of documents, formats, forms, and/or information related to the Department. Coordinates and ensures constant and effective communication with other company departments for the intervention and/or requests for information required to support the completion of projects and/or activities related to the department, according to operational need. Coordinates the planning of the Quality Department's meetings as required. Keeps track of standards, documentation, binders, and applications in preparation for audits and Administrative Quality processes. Maintains the supervisor informed of the status of tasks related to Quality projects to keep them notified of the progress of these projects. Supports different administrative tasks related to the Model of Care, AAAHC accreditation and other projects, as needed. Performs presentations for the Administrative Quality initiatives as required. Digitalize documents and different information in the corresponding Administrative Quality folders. Keeps electronic files organized and in the required formats to present and use as reference as required. Maintains records, documentation, and folders for each project, request, and/or special event to be used as reference. Receives, answers, and effectively forwards calls and/or requests received in the department and monitors for resolution in cases that merit it. Supports the submission of reports required by regulatory agencies promptly and as requested (ASES, CMS, Other Departments) among others. Validates and determines the procedures to be conducted to refer requests to the corresponding areas, maintains a record of said procedures, and provides follow-up. ADDITIONAL FUNCTIONS: Must comply fully and consistently with all company policies and procedures, with local and federal laws as well as with the regulations applicable to our Industry, to maintain appropriate business and employment practices. May carry out other duties and responsibilities as assigned, according to the requirements of education and experience contained in this document. MINIMUM QUALIFICIATIONS: Education and Experience: Associate's degree, preferably in Business Administration, Management, Accounting, or relatedareas. At least one (1) year of experience performing administrative and coordination tasks. "Proven experience may be replaced by previously established requirements." Certifications / Licenses: N/A Other : N/A Languages: Spanish-Advanced (writing, reading, and conversational) English-Advanced (writing, reading, and conversational) Job Type: Full-time Salary: From $13.00 per hour Expected hours: 38.5 per week Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. Engineer, Sr Process Works cross-functionally to lead process development of complex technologies on new products and ensures efficient and effective transfer of product into production. Key Responsibilities * Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects. * Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation. * Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems. * Plans, organizes, and conducts all aspects of technical reviews. * Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM's, Routers, FMEA's, etc.) * Writes and reviews validation protocols and reports applicable to new processes. * Oversees development builds associated with the project using special work requests. * Develops qualified production lines. * Provides Design for Manufacturability (DFM) input to the engineering print package. * Contributes ideas to or generates Intellectual Property submissions. * Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation. * May serve as a core team member or extended team member on new product projects. Management Requirements * BS in Engineering with 5+ years of related experience or an equivalent combination of education and work experience * Mechanical or Biomedical Engineer preferred. * Experience leading complex projects. * Knowledge in statistical analysis * Design of Experiments (DOE) experience * Failure modes analysis * Preferred Experience: Silicone Molding, CAD knowledge, Equipment integration/ Mechanical Design, Vision systems development, Cross-Functional Teamwork (technical), Medical device or other regulated industry experience with exposure to Operations or New Product Development. * Open to travel * Fully Bilingual Requisition ID: 597518 Minimum Salary: $61900 Maximum Salary: $117600 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see ******************************** vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements. For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. Nearest Major Market: Puerto Rico Nearest Secondary Market: San Juan Job Segment: Biomedical Engineering, Statistics, Medical Device, Business Process, Engineering, Data, Healthcare, Management, Quality

**About the team:** The Information Security organization advances the overall state of security at Rubrik through critical initiatives and coordination of large security projects. Information Security builds technologies, tools, and processes to better enable teams at Rubrik to develop secure software and protect data and systems with appropriate security controls. Information Security also develops systems to monitor and respond to attacks against our assets, provides awareness education to teams on security best practices for data protection, and ensures data governance and data sharing relationships with third parties in order to securely protect Rubrik information. **Where can you make an impact?** Rubrik is seeking creative problem solvers with a passion for cyber security. In this role you will partner with all parts of the business to build security solutions that help secure the brand and protect the organization, company and customer environments. You will be responsible for executing security engineering programs and managing security technologies across the board. The ideal candidate for this role is someone who can build innovative ways to deliver frictionless security capabilities to enhance the security posture of the organization. **What you'll do:** + Deploy and operate security solutions and supporting infrastructure in cloud and datacenter environments in support of internal customer security needs and FedRAMP requirements + Develop and automate Security tasks that span from Security Operations to Infrastructure as Code in support of InfoSec initiatives + Manage the availability, capacity and configuration of InfoSec's mission critical applications and services + Define, measure and monitor SLAs & SLOs for systems and services with the objective of achieving and exceeding availability and reliability goals + Manage and streamline monitoring systems to enhance observability and enable proactive identification of issues. + Coordinate and manage incidents, upgrades and changes for InfoSec's applications and services + Drive post-incident analysis with partner teams and/or vendors to identify root cause and ensure preventative measures are implemented promptly + Assist in Security Incident investigations + Manage a scalable and highly available solution for security logging and drive efforts of logging onboarding for increased security visibility + Perform Production Readiness Assessments of new services to identify reliability needs and surface potential gaps + Develop and maintain documentation and runbooks to reduce MTTR and inform future automation development + Work cross functionally across global time-zones requiring flexible work hours + Participate in 24/7 on-call rotations **Experience you'll need:** + Bachelor degree in Computer Science or related field or equivalent experience + 8+ years experience in security engineering, building and managing security solutions across the stack (on-prem and cloud) + Strong understanding of logging and data management best practices and strong experience in any logging and/or SIEM platform + Experience with Vault, Terraform, Puppet, Jenkins and Github + Proficiency in any scripting language (Python, PowerShell, Perl, Ruby, shell, etc.) + Working experience in GCP, AWS or Azure + Operational knowledge of Linux and Windows systems + Experience with with security automation and data management tools (XSOAR, Phantom, Snowflake, etc) + Prior experience working in environments with NIST 800-53, NIST 800-171 controls or FedRAMP requirements **Preferred Qualifications:** + Security certifications are a plus (CISSP, CISM, SANS certs, vendor certs, etc.) + Experienced knowledge of container technologies (Docker, Kubernetes, etc), microservices and CI/CD pipelines **Security and Privacy Responsibilities** **:** This position carries special Security and Privacy Responsibilities for protecting the U.S. Federal Government's interests: + Know, acknowledge, and follow system-specific security policies and procedures; + Protect data and individual privacy per requirements and regulations; + Perform ongoing activities in compliance with service and contractual obligations; + Participate in role-based training, completing assignments on a timely basis; + Report security issues promptly, and aid investigation when needed; + Support controlled changes and vulnerability remediation activities; and + Work collaboratively with Information Security in designing, implementing, assessing or enhancing system-specific security and privacy controls. **Position Risk Designation** section: This position carries duties and responsibilities involving the U.S. Federal Government's interests. The selected incumbent may be subject to one or both of the additional background checks with periodic re-screening as noted below: **Position Risk Designation: Non-Sensitive, Low Risk, Tier 1** _Incumbents without access to U.S. Government data may be required to complete Standard Form 85 and undergo a Tier 1 Investigation (T1) for non-sensitive positions of Low Risk. (Baseline screening; formerly National Agency Check and Inquiries (NACI))._ **Position Risk Designation: Non-Sensitive, Moderate Risk, Tier 2 (Public Trust)** _Incumbents with access to U.S. Government data may be required to complete Standard Form 85P and undergo Tier 2 (T2) Investigation for non-sensitive positions designated Moderate Risk._ **Position Risk Designation:Moderate Risk Law Enforcement (CJIS)** _When hired for a position where access to Moderate Risk criminal justice information is required, the employee must complete a fingerprint-based national criminal history background check within 30 days after the employee's start date._ The minimum and maximum base salaries for this role are posted below; additionally, the role is eligible for bonus potential, equity and benefits. The range displayed reflects the minimum and maximum target for new hire salaries for the role based on U.S. location. Within the range, the salary offered will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. US (SF Bay Area, DC Metro, NYC) Pay Range $172,000-$258,000 USD The minimum and maximum base salaries for this role are posted below; additionally, the role is eligible for bonus potential, equity and benefits. The range displayed reflects the minimum and maximum target for new hire salaries for the role based on U.S. location. Within the range, the salary offered will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. US2 (all other US offices/remote) Pay Range $154,800-$232,200 USD **Join Us in Securing the World's Data** Rubrik (NYSE: RBRK) is on a mission to secure the world's data. With Zero Trust Data Security, we help organizations achieve business resilience against cyberattacks, malicious insiders, and operational disruptions. Rubrik Security Cloud, powered by machine learning, secures data across enterprise, cloud, and SaaS applications. We help organizations uphold data integrity, deliver data availability that withstands adverse conditions, continuously monitor data risks and threats, and restore businesses with their data when infrastructure is attacked. Linkedin (******************************************************************** | X (formerly Twitter) (****************************** | Instagram (************************************* | Rubrik.com **Diversity, Equity & Inclusion @ Rubrik** At Rubrik we are committed to building and sustaining a culture where people of all backgrounds are valued, know they belong, and believe they can succeed here. Rubrik's goal is to hire and promote the best person for the job, no matter their background. In doing so, Rubrik is committed to correcting systemic processes and cultural norms that have prevented equal representation. This means we review our current efforts with the intent to offer fair hiring, promotion, and compensation opportunities to people from historically underrepresented communities, and strive to create a company culture where all employees feel they can bring their authentic selves to work and be successful. **Our DEI strategy focuses on three core areas of our business and culture:** + Our Company: Build a diverse company that provides equitable access to growth and success for all employees globally. + Our Culture: Create an inclusive environment where authenticity thrives and people of all backgrounds feel like they belong. + Our Communities: Expand our commitment to diversity, equity, & inclusion within and beyond our company walls to invest in future generations of underrepresented talent and bring innovation to our clients. **Equal Opportunity Employer/Veterans/Disabled** Rubrik is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Rubrik provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Rubrik complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please contact us at ************* if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. EEO IS THE LAW (************************************************************************************* EEO IS THE LAW - POSTER SUPPLEMENT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (********************************************************************************************** NOTIFICATION OF EMPLOYEE RIGHTS UNDER FEDERAL LABOR LAWS

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!

The Opportunity This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. * Reporting compliance status data to operational quality management * Collaborate with center management in the development and implementation of continuous improvement plans * Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns * Responsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role * Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. * Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. * Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. * Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements. * Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. * Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used * Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. * Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. * Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. * Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. * Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. * Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. * Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. * Follow all Standard Operating Procedures (SOPs), company policies and procedures. * Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. * Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. * Assist Plasma center staff in completing other special projects or assignments, as requested. * Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience Education High school diploma or equivalent required. Associate or Bachelor's degree in business administration or biological sciences preferred. Experience * Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. * Strong customer service skills * Strong critical reasoning, decision-making and problem solving skills to analyze situations * Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives * Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) * Occasionally required to work with the public when they are dissatisfied * 80% of the time standing and walking and 20% of the time sitting * Reach, bend, kneel and have high level of manual dexterity * See and speak with customers and observe equipment operation * Occasionally be required to lift and carry 25 lbs. * Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL!

**Mentor Technical Group** **Reliability Engineer (Regulated Industry)** **Caguas, Puerto Rico - Full Time** *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:** * Lifecycle Asset Management (LCAM) & Reliability Programs * Partner with stakeholders to drive life cycle asset management across strategic accounts. * Lead the Maintenance Excellence & Life Cycle Asset Management (LCAM) Program at sites according to corporate standards. * Ensure quality work execution and maintain technical excellence. * Engage and collaborate with client leadership. * Collaborate on dashboards and scorecards with a focus on user-centric design and real-time monitoring and analysis. * Fully implement the corporate engineering standard at site level. * Ensure the quality of CMMS Master Asset Data. * Develop Bill of Materials (BOMs) and critical spare parts program. * Ensure CMMS maintenance plans are in place for critical assets. * Track project-generated documents and ensure CMMS is updated accordingly. * Execute risk and opportunities management assessments according to company procedures. * Drive the Risk Based Asset Management Program (RBAM) for the account. * Promote continuous improvement through PMO, PdM, and FMEA. * Smart Building Program: Drive continual improvement in predictive and condition-based maintenance leveraging current and future Smart Building technologies. * Perform asset appraisals to determine the optimum maintenance regime and effective deployment of condition-based maintenance leveraging installed smart building sensors. * Propose opportunities to increase the condition-based maintenance deployment and include all associated costs and resources necessary to implement such solutions. * Provide data insights that inform the Smart Building program's effectiveness that include factors such as impact on reliability, asset cost, resource optimization, and energy efficiency. **Qualifications Requirements/Knowledge/Education/Skills:** * Bachelor's degree in Engineering, Reliability Engineering, or a related field. * Proven experience in reliability engineering or a similar role. * Strong analytical and problem-solving skills. * Proficiency in CMMS and asset management software, preferably SAP. * Excellent communication and collaboration skills. * Ability to manage multiple projects and priorities. * Knowledge of industry standards and best practices in reliability engineering. * Knowledge of IoT technology for Smart Buildings * Preferred Qualifications: Experience with engineering standards implementation. * Familiarity with risk-based asset management and continuous improvement methodologies. * Strong understanding of asset management practices. **Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.** ***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.***

**Department:** Field - LL **Location:** Arecibo, 013 ***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: * **Quality Engineer I** Responsibilities: * Leads and participates actively in identifying and implementing actions to ensure continuous improvement of the Quality System and processes within the ISO platform including activities such as preparation / validation of procedures, conducting internal audits, and generating PCAR's. * Conducts / leads or participates in Process Mapping , FMEA, ACP's and Nine Step Problem Solving initiatives to promote and ensure that processes are continuously improving and operating in a waste elimination mode. * Facilitates / leads implementation of processes required to achieve elements of the facility strategic plan and Scorecard objectives including elements such as Five S, ISO, Ergonomics program and Operational Excellence Plan. * Gathers and analyzes information to evaluate current work processes in order to determine the flow of work, time requirements, costs, and duration. * May supervise department employees, as required. * Develops strategies and programs that improve the productivity and efficiency of the various work processes of the company. * Execute various types of quality audits. Identify opportunities and develop plans to close gaps. * Instructs others in continuous process improvements, including the use of various problem solving and productivity techniques such as process mapping and cost time management. * Develops and coordinates programs to recognize groups or individuals for quality / continuous improvement actions. * Participate actively in MDI, SQDIP and other meetings as required. * Coordinate and/or attend meetings, as required. * Performs other duties and projects as assigned. * Maintain the work area clean and organized. * Comply with company policies and procedures, including EHS and ISO requirements. **Qualifications:** - Bachelor's degree in Engineering. - Minimum 3 years' experience in quality. - Computer knowledge (MS Office). - Excellent interpersonal skills. - Excellent written and oral communication skills in English and Spanish. - ISO Knowledge. - Customer service oriented. - EIT and active member CIAPR.

**The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. + Reporting compliance status data to operational quality management + Collaborate with center management in the development and implementation of continuous improvement plans + Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns + Responsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality **The Role** + Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. + Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. + Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. + Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements. + Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. + Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used + Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. + Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. + Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. + Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. + Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. + Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. + Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. + Follow all Standard Operating Procedures (SOPs), company policies and procedures. + Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. + Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. + Assist Plasma center staff in completing other special projects or assignments, as requested. + Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job **Your skills and experience** **Education** High school diploma or equivalent required. Associate or Bachelor's degree in business administration or biological sciences preferred. **Experience** + Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. + Strong customer service skills + Strong critical reasoning, decision-making and problem solving skills to analyze situations + Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives + Understand Quality Systems and/or regulated training requirements **Working Conditions** (physical & mental requirements) + Occasionally required to work with the public when they are dissatisfied + 80% of the time standing and walking and 20% of the time sitting + Reach, bend, kneel and have high level of manual dexterity + See and speak with customers and observe equipment operation + Occasionally be required to lift and carry 25 lbs. + Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors **Our Benefits** We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care (******************************************************* at CSL. **About CSL** CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL (******************************** . **We want CSL to reflect the world around us** As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion (**************************************************** at CSL. **Do work that matters at CSL!** R-248357 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. ************************************************