Quality manager jobs in Puerto Rico - 68 jobs

Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on **Director of Quality** to lead product and supplier quality assurance efforts within our **Life Sciences business unit** , which includes the **Datavant Connect** and **Aetion Evidence Platform** . These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is essential to operationalizing Datavant's **Quality Management System (QMS)** across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments. **What You Will Do** + Lead the development and continuous improvement of Datavant's QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance. + Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring. + Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation. + Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring. + Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives. + Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners). + Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP. + Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation. + Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality program in external communications, including client onboarding, RFIs, and quality-related escalations. **What You Need to Succeed** + 8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations. + Strong working knowledge of relevant regulations and frameworks, including **FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** , and **GDPR** . + Proven leadership in scaling and operationalizing a **QMS in a SaaS, RWD, or GxP context** . + Experience managing and mentoring cross-functional teams. + Demonstrated success overseeing **validation, supplier oversight, internal audits, and CAPA management** . + Deep understanding of **data governance, privacy, and security** best practices. + Experience interacting with external auditors, customer compliance teams, or regulatory agencies. + Strong communication skills-capable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders. **What Helps You Stand Out** + Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions. + Background working in or with tokenization, health data linkage, or privacy-enhancing technologies. + Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams. + Training or certification in Six Sigma, ISO Auditing, or software validation methodologies. + Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl). + Experience contributing to industry working groups on quality, data integrity, or health data compliance. \#LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is: $165,000-$230,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here (************************************************** . Know Your Rights (*********************************************************************** , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, (************************************************************** Id=**********48790029&layout Id=**********48795462) by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here (******************************************************************************************************* . 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For Scheduling services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or Sciences and five (5) years of experience within the Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Negotiating and Conflict Resolution skills Shift: 1st, 2nd, and according to business needs. Experience in: Risk Management/Critical Thinking Hands-on Experience on Projects/Scheduling for Medical Device manufacturing. Leading cross-functional team and leveraging solid PM skills (project planning, communication, risk management). Problem solving methodologies (DMAIC, process map, 5 whys). The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight, continuingly to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages. Prepares reports and/or necessary documentation (ex, Corrective and Preventive Actions) and provides to applicable stakeholders. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally. Is accountable for the overall program process, performance, and customer satisfaction. WHO WE ARE: We are a service provider company that is different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

At INVID, we're looking for a skilled and experienced QA Manager to lead our quality assurance initiatives across web and mobile platforms. This is a key leadership role requiring deep expertise in software testing, managing QA teams, and designing automated testing pipelines. The ideal candidate excels in evaluating applications for performance, security, usability, accessibility, scalability, and reliability, leveraging both manual and regression testing methods. Beyond testing proficiency, the QA Manager will be responsible for building and mentoring QA/QC teams, recruiting top talent, conducting internal audits, and driving continuous improvement through well-defined QA metrics and SOPs. What sets INVID apart is our collaborative and flexible work environment. We encourage our team to raise the bar in everything they do while maintaining a healthy work-life balance. With our hybrid work model, team members thrive both in the office and remotely. We foster a culture of mutual respect, autonomy, and accountability, where your voice matters and your growth is supported. From structured career paths and paid professional development to access to industry events, we're committed to your success. Position Overview We are seeking a Quality Assurance (QA) Manager to lead and evolve our QA practice. This role is essential to ensuring the delivery of reliable, secure, and user-friendly software solutions across web and mobile platforms. The ideal candidate will bring deep expertise in modern testing methodologies, automation, and DevSecOps practices, along with strong leadership and strategic thinking. Key Responsibilities Lead and mentor a team of QA engineers and analysts across multiple projects. Design and implement comprehensive QA strategies that include: Functional Testing (manual and automated) Regression Testing Security Testing Accessibility & Usability Testing Performance & Load Testing Web and Mobile App Testing Promote and integrate DevSecOps principles into QA workflows. Collaborate with development, product, and operations teams to ensure quality throughout the SDLC. Drive adoption of CI/CD pipelines and automated testing frameworks. Define and track QA metrics to measure effectiveness and identify areas for improvement. Contribute to the Center of Excellence by standardizing QA processes and fostering innovation. Required Skills & Experience Bachelor's degree in computer science, Engineering, or related field. 5+ years of experience in software QA, with at least 3 years in a leadership role. Strong knowledge of testing techniques including: Black-box, White-box, and Gray-box testing Boundary value analysis, equivalence partitioning, exploratory testing Security testing tools (e.g., OWASP ZAP, Burp Suite) Accessibility standards (e.g., WCAG) and usability testing methods Performance testing tools (e.g., JMeter, LoadRunner) Experience with test automation frameworks (e.g., Selenium, Cypress, Appium). Familiarity with Agile/Scrum development environments. Hands-on experience with CI/CD tools (e.g., Jenkins, GitLab CI, Azure DevOps). Knowledge of DevSecOps practices and integration of security into QA processes. Excellent communication, leadership, and problem-solving skills. Bilingual (Spanish/English) preferred. Bilingual: English and Spanish US Citizen | US Resident Location: San Juan, PR EEO

LUMA - Built for Puerto Rico We rely on electricity every day. We need it to run our appliances, power the streetlights and produce the goods and services that drive our economy. At LUMA we are committed to provide Puerto Rico with electricity that we all can depend on. At LUMA, we put people first - our employees, our customers and the communities where we live and work. We encourage and inspire our people to embrace opportunities as they work to build an electricity system that will make Puerto Rico a better place. If you're looking for a career where you can make a tangible difference in the lives of your neighbors and your community, LUMA is the place for you. LUMA offers new jobs designed to respond to the current and future needs of the T&D system. Together we're transforming the island's electric transmission and distribution system, and energizing Puerto Rico. Please note that these new jobs with LUMA offer different terms and conditions of employment to those currently in place with PREPA. We will schedule interviews with all qualified PREPA candidates. All PREPA applicants will receive priority in hiring and a compensation package equal to or better than what they receive today. In order to receive notifications as additional positions and locations are posted, please create a profile on our career site. About the Position Reporting to the Section Manager, PMO, this is a leadership position that provides supervision, administration, coordination, and accountability to lead PMO quality management for the Capital Programs department. This role is responsible for effectively implementing quality assurance and control on any PMO-produced processes, standards, and artifacts to ensure the organization can quickly learn and adapt to them. This role will be responsible for ensuring compliance and adherence against internal and external regulations; and for conducting comprehensive reviews and audits of each project phase of the project life cycle. What will you get up to everyday? Lead the creation and implementation of quality management strategies and plans to achieve excellence through quality. Consult with Managers and/or Sponsor to identify suitable projects for Audits based on successes and opportunities for continuous improvement. Meet with Project Managers at the end of each phase to review the utilization of methodologies and tools. Identify gaps against applicable Regulatory & Legislation and develop recommendations for review with the PMO Manager. Finalize recommendations for review/approval with applicable Manager(s) and/or Project Sponsor. Prepare monthly report for the PMO Manager advising on the progress of Audits, including performance on utilization metrics. Consolidate monthly reports into a high-level, quarterly report for review by Senior Management. Working with PMO Team and technical writer(s), create & amend audit methodologies and tools to incorporate recommendations. Implement and/or improve a Lessons Learned Program, communicating and evaluating them and supporting continuous improvement of the organization through this program. Support the review and approval function for finalizing updated documentation. Ensure finished documentation is posted to the PMO SharePoint and metadata is updated as required. Prepare and send out an implementation notice to the PMO user community when new or updated documents are ready for implementation. Regularly communicate with Project Managers the audit status of their projects. Be available and open to Project Managers wanting to provide comments and suggestions. Present Audit highlights at monthly knowledge transfer sessions. Establish, monitor, and report on project management (utilization) audit metrics, prepare reports, and present key audit findings to senior management. Other duties, as required. Leadership Responsibilities Yes What We are Hoping You Bring to LUMA LUMA's culture is rooted in the concept of People First, Safety Always. We want your knowledge and expertise to pair with LUMA's globally recognized experts in numerous fields such as customer service, field workforce development, high-voltage transmission engineering, distributed energy resources and mini/micro grid integration. Our employees receive substantial training and development, as well as opportunities for advancement and success. Within our People First, Safety Always culture, we're committed to offering continuous learning opportunities and career-long support for our employees. Education Undergraduate degree in Engineering, Commerce, Economics, Business, or Technical Institute. Project Management training/certification (i.e. PMP) or equivalent relevant experience would be considered an asset. Experience Minimum of 5 years of Project Management experience in a utility or EPC environment. Demonstrated understanding and skills in performing audits. Excellent written and verbal communication skills as well as advanced listening and comprehension skills. Strong interviewing and interpersonal skills required to interview project team members and management, and translate targeted information into audit reports and recommendations. Ability to remain flexible, adapt, and quickly comprehend project influences from other LUMA Departments (as required). Excellent time management skills to effectively generate, prepare and manage quality work under stringent timelines. Excellent organizational skills and strong ability to prioritize and execute multiple work requirements simultaneously. Ability to work independently and collaboratively on projects and exercise discretion and confidentiality where required. Proficient in Microsoft Office and SharePoint applications. Licenses/Certifications Valid Driver's License. More Details on what to expect with this position at LUMA space Travel Requirements Office based Travel: Up to 10% Physical Demands Stationary Position: Constantly Pushing/ Pulling/ Reaching: N/A Climb: N/A Kneel: Seldom Grab: Seldom Bend: Seldom Lift/ Carry over: Less than 5 LBS Vision: 20/20 Corrected Vision Hearing: Receive detailed information if spoken to. Working Conditions Wet or humid: N/A Working near or on moving mechanical parts: N/A Working near or on heavy machinery: N/A Working in high places: N/A Exposed to fumes or airborne particles: N/A Exposed to toxic or caustic chemicals: N/A Frequency of working in outdoor weather conditions: N/A Work with electricity: N/A Work with explosives: N/A Work on or near a source of radiation: N/A Loud Noise conditions (abover 87 db): N/A Other environmental factors including weather conditions: N/A Other: We are looking forward to seeing your application! You made it to the end of the job posting! Thank you for expressing interest in LUMA and taking the time to read all the details of this position. We encourage you to apply and give us the opportunity to get to know you better through the recruitment process. Together, we're energizing the people of Puerto Rico. Note: this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, working conditions, physical demands, and activities may change or new ones may be assigned at any time with or without notice. LUMA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 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.

Validation & Engineering Group (V&EG) is a leading services supplier 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. Job Description Accountable to provide Quality oversight of FP Technologies method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to FP Core Technologies and/or to sites. Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites. Works with External Supply Quality and/or other quality counterparts to ensure there is a robust plan in place when receiving methods from a CMO or supplier. Provides Quality oversight to final product core technologies activities and deliverables Quality approval of protocols and technical reports for method development Masters/Bachelors Degree in Science or Engineering Why is the Position Open? additional workload on the team Top 3 Must Have Skill Sets: hard skills (5+ years of experience) Validation Qualifications experience Combination process / Medical Devices experience GMP experience (quality management systems, manufacturing) Audits / Inspections experience Qualifications Top 3 Must Have Skill Sets: hard skills (5+ years of experience) Validation Qualifications experience Combination process / Medical Devices experience GMP experience (quality management systems, manufacturing) Audits / Inspections experience Additional Information Positions available for Puerto Rico. Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.

Ultimate Solutions Corp is a global leader in compliance and technology solutions, specializing in end-to-end integrated services for the Life Science industry. With 20 years of experience, we have built core competencies by combining regulatory and quality expertise with advanced packaging automation, serialization, brand protection, and IT services. This unique blend of capabilities has enabled us to expand our reach to client worldwide. RESPONSIBILITES Equipment (testing) validations, Support investigations and CAPAs Test method validations Approval of Documents Applies basic Quality Engineering principles along with Six Sigma tools to design and implement system or process modifications. Candidate must have experience in Sampling Plans, Change Controls and pFMEA creation and review. EDUCATION Bachelor's degree in Engineering (3 -5 years of experience) REQUIREMENTS/SKILLS Experience in Medical Device or Pharmaceutical industry is required GMP & ISO knowledge, understanding and experience Computer skills and use of software application(s). Strong computer background (MS Office, MS Project Management, Word, Excel, Outlook, etc.) Strong knowledge on statistics, problem solving and lean tools. Effective interactions in a team environment Team player, self-starter, persistent, tactful, and persuasive Good organizational skills, detail-oriented & accurate, analytical skills Effective verbal and written communication skills (writing and presentations) Able to work with minimum or no supervision Shift: Administrative and according to business needs. Fully Bilingual (English and Spanish) Ultimate Solutions Corp is an equal opportunity employer.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Manger, Quality Control will manage and provide direction within the Quality Control Laboratory and Incoming Samples areas. The position holder will handle all matters concerning the compliance of QC assuring that all processes and documentation meet cGMPs, GLPs, regulations and quality policies. The incumbent will work independently, having a thorough knowledge of plant operations, and ability to communicate to all levels of management. This role will lead and direct the staff that performs the sampling, chemical and microbiology testing promoting a self-managed organization. The Manager, QC will provide technical oversight to the QC team to assure proper and prompt resolution of situations that could impact product efficacy, purity and safety. This role will maintain close communication with production and functional areas to pursue proper coordination of the QC activities and avoid business interruptions. The incumbent will act as site Subject Matter Expert (SME) in QC technical aspects as well as maintain a continuous improvement philosophy leading innovation and challenging the status quo. **Duties & Responsibilities** + Provides direction, delegates and removes obstacles to assure completion of QC sampling and testing. + Plans and prioritize to meet business commitments aligned with organizational goals. + Facilitates the activities assuring proper reagent inventory, and equipment spare parts etc. + Maintains close communication with production and functional areas to assure QC testing and incoming sampling meet required schedules. + Oversees and strategically supports the proper administration of the Stability Program including evaluation of trends/testing at appropriate intervals as per NADA/Regulatory commitments. + Strategically works with QC Supervisors to assure technical adequacy of the scientific documents and testing methods used within Quality Control departments. + Provides technical expertise and guidance during investigations of events or deviations. Coordinates and/or conducts the investigation if necessarily. + Leads innovation based on area needs and opportunities for new technology to optimize processes maintaining compliance posture. + Develops strategy, leads and works in coordination with GMSAT and LMSAT transfer of new products into QC. + Supports site transfers through strategic leadership and direction ensuring robust processes and compliance. + Participates in meetings as SME to provide input or support for manufacturing, quality, or other topics. + Revises, provides impact assessments and approves Change Control documents as QC SME. + Prepares and allocates the department budget for Quality Control. + Monitors spending and proactively identify any negative trends and explore actions to avoid it. + Identifies and explores new ways for savings to improve spending. + Provides strategic direction on general data integrity compliance in all areas within QC. + Works with QC team to determine area needs and opportunities. + Facilitates the acquisition, installation and qualification for new laboratory instruments and Incoming area equipment, as required. + Assures laboratories and Incoming areas maintain continuous Inspection readiness. + Responsible for compliance with industry guidelines and regulations. + Primary contact during an inspections and audits of the QC areas. + Directs and assures responses to all previous regulatory and internal cGMP's observations related to the QC areas are done in a consistent and compliant fashion. + Empowers, motivates and drives people development. + Assures timely completion of annual performance review activities. + Promotes and engages with direct reports by conducting frequent 1:1's to discuss career development opportunities, supports annual TDD activities and assures individual development plans are up to date and aligned with site priorities and strategic business needs. + Role models highest ethical and professional standards performing all Company business in accordance with all regulations (e.g., FDA, EMEA, HC, etc.) and Company policy and procedures. + Immediately escalates as appropriate, any violations to regulations. + Leads and models a culture of quality and continuous improvement in the organization. + Drives an improvement mindset, implement ideas, programs and change management initiatives that will have sustainable long-term benefits according to the organization strategic goals and objectives. + Assures overall compliance with all environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any environmental events within the QC area. + Actively engages and role models behaviors aligned with the site EHS philosophy and assures full on-time compliance with applicable EHS training programs and requirements. **Requirements** + Bachelor's degree in microbiology, chemistry or related scientific area and between seven to eight (7-8) years of relevant industry experience in a GMP in pharmaceutical production environment; Master or PHD degree is preferred. + Minimum of five (5) years in a laboratory management environment leading a substantial number of employees. + Strong understanding of external regulations e.g., FDA, EMEA, ICH and others. + Demonstrates ability to work and communicate with diverse groups across the organization at managerial levels and below on a routine basis. + Excellent organizational, supervisory, and leadership skills to manage a team and technical staff. + Technical English and Spanish, oral and written communication. + Leadership skills, including but not limited to delegation, motivation, influencing, conflict management, teamwork, and negotiation. + Problem solving and decision-making skills. + Ability to work with people at all levels. + Conflict resolution and technical writing skills. + Root cause analysis and problem solving. + Influencing and negotiation skills. + Communication skills in Spanish and English (technical), verbal and written. + Ability to analyze complex problems in technical systems to gather conclusions of its functionality. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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: • Review plant defect reports, customer complaints, failure investigations and audit findings to assess manufacturing related issues that may impact quality and recommend courses of corrective action. • Conduct manufacturing non conformances investigations, customer complaints, CAPA, failure investigations and audit findings. • Escalate manufacturing related issues that may impact quality and recommend courses of corrective action. • Participate in regulatory agencies audits. • Assist in the investigation of product non conformances and the gathering of information during regulatory inspections and field actions when required • Approve or review product investigations reports. • Perform and report line defects trend analysis, cost of quality, and period quality summaries. • Participate in new product or technology transfers to assess the impact they may have on the quality and reliability of the product - assist in process validation protocol. • Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends. • Perform quality system audits to determine compliance to FDA, ISO, and internal quality systems regulations and perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or contractor. • Participate in the development, delivery, and administration of quality training programs including but not limited to GMP. • Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement. • Provide leadership and guidance to a team of hourly or salary associates, including assigning tasks, setting clear goals, and monitoring performance, as required. • Facilitate training sessions to ensure team members are equipped with necessary skills and knowledge. • Develop individual team members through coaching and mentoring. Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree in Engineering o rwlated Sciences (Industrial, or CQE preferred), advanced degree or process towards advanced degree is a plus. o A minimum of (7) seven years' experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry 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.

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

Our Supplier Quality Engineer (SQE) for Non-Destructive Evaluation (NDE) & Testing Processes, will apply their demonstrated knowledge of NDE to lead improvement and sustain quality practices within our Composites supply chain. SQE Deliverables Include: - Support supplier process quality strategy for GE Aerospace. - Drive quality for assigned suppliers, including quality plan implementation. - Lead suppliers through root cause and corrective actions to address any quality findings. - Select suppliers through qualification processes. - Own supplier quality system requirements, drive improvements utilizing supplier scorecards. - Own supplier audits, ensuring compliance, and driving improvement plans where needed. - Mentor team members within the Composites supplier quality team. - Demonstrate an in-depth understanding of key business drivers; uses this understanding to accomplish own work. - Demonstrate an in-depth understanding of how work within our own team integrates with other teams and contributes to the area. **Job Description** **Roles and Responsibilities** + Role is responsible for supplier processes, from initial qualification, maintenance, and necessary improvement driven by business quality needs. + Position includes regular supplier audits, in conjunction with our GE Aerospace process experts and system assessments for quality preparedness and process controls to remain adherent to GE Aerospace process specifications and agency regulations. + Requires specialized knowledge within the field of NDE, including but not limited to: CT Scanning & Ultrasonic evaluation processes. Influence the development of strategy for the area of responsibility, including control of resources and influences policy formulation. + Interprets simple internal and external business challenges and recommends best practices to improve products, processes, or services. Stays informed of industry trends that may inform work. Coordinating with the GE Aerospace Inspection Solutions (AIS) experts and operations teams and their approved supplier technical plans, to ensure product meets the approved process requirements and specifications. + Uses high level of judgment to make decisions and handle complex tasks or problems in areas of operational, product management, manufacturing, technology, or engineering. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and can construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision. + May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on specific topics. May guide others to consider a different point of view. **Required Qualifications** + Bachelor's Degree from an accredited college or university (or a high school diploma/GED with a minimum of 4 years (Materials Science, Physics, Chemistry, Mathematics, or Engineering) experience + minimum of 3 years (Materials Science, Engineering, or Quality) related roles experience **Desired Characteristics** + demonstrating proficiency of their time within Non-Destructive Evaluation operations, team leadership, and aerospace supply chain familiarity. + Demonstrated expertise and experience with Non-Destructive Evaluation and Testing + Proficiency in reading and applying engineering drawings and specifications. + Demonstrated organizational leadership in quality systems foundations and adherence, via industry requirements and audit experience. + Demonstrated experience in manufacturing or supplier quality, statistical analysis + Certified or willingness to achieve a Level 2 NAS410 qualification for certification in CT, and UT + Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. + Demonstrated history of problem solving, root cause and corrective action methodology, data analysis and quality experience + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Focused: quick learner, strategically prioritizes work, committed + Leadership ability: strong communicator, decision-maker, collaborative + Problem solver: analytical-minded, challenges existing processes, critical thinker The base pay range for this position is 110-130k. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on [include anticipated date expected to close December 1. 2025. GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** No \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

The Quality Engineer will support the development, review, and maintenance of quality systems and documentation in a regulated manufacturing environment. This role focuses on validation oversight, document evaluation, and continuous improvement of inspection and assembly processes. Responsibilities: Execute and support Test Method Validation and Cleaning Validation activities. Update and create inspection methods for products / components. Review / update instructions for manufacturing control inspections and other related documentation. Review validation documents such as IQ, OQ, PQ. Review and manage investigations. Collaborate with cross-functional teams to ensure compliance with internal and external quality standards. Support CAPA investigations, root cause analysis, and corrective actions. Participate in audits and regulatory inspections as needed. Other functions that may be assigned. Qualifications: Bachelor's degree in Engineering or related field. Minimum of 5 years of experience in Quality Assurance or Engineering within a regulated industry (medical device preferred). Knowledge of validation protocols. Strong analytical, documentation, and communication skills. Fluent in English and Spanish preferred. Work Methodology: 100% On-site & full-time project 13 months (1st contract) Administrative Shift (if a special validation is required, a second shift may need to be scheduled based on the need). Professional services contract

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Develops, modifies, applies and maintains quality standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develop and implements methods and procedures for inspecting, testing and evaluating products and production equipment. Performs statistical analysis. Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality. Performs and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory). Qualifications: Bachelor's degree in Mechanical, Electrical or Chemical preferred (not Science) Minimum of 5 years of relevant experience on field (quality - excluding experience laboratory micro/chemistry) or engineering or programming. Experience in Change Control of Medical Devices. Basic knowledge in Probability and Statistics (preferably using Minitab). Knowledge of equipment Commissioning/Qualification. Knowledge of Process validation and Computer software validation (e.g. requirements flow down from design to manufacturing). Knowledge of Manufacturing, Packaging and Laboratory equipment. Technical experience (Troubleshooting) or any similar experience or background. Knowledge of Quality/Process Control/Assurance of Medical Devices. Investigation and root cause analysis skills. Experience with Risk management documentation: pFMEAs. Experience investigating manufacturing operations events in support to product disposition. Experience assessing and tracing manufacturing defects/rejects trends. Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence). Organization and Communication skills. Technical writing knowledge. Knowledge in Medical Devices regulations. Availability for 1st and 2nd shifts and weekends (it will depend on production schedule - projects will be executed at different time shifts, sometimes on weekends). Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers 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 the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Responsibilities: * Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards. * Collaborates with engineering and manufacturing functions to ensure quality standards are in place. * Develop and implements methods and procedures for inspecting, testing and evaluating products and production equipment. * Performs statistical analysis. Ensures that documentation is compliant with requirements. * May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality. Shift: 1st and 2nd shift and weekends (it will depend on production schedule - projects will be executed at different time shifts; sometimes on weekends) Location: Juncos, PR Education: Engineering degree: Mechanical, Electrical or Chemical preferred (not Science) Years' Experience Required: min. 5 yrs on field (quality - excluding experience laboratory micro/chemistry ) or engineering Preferred Qualifications: * Experience with Risk management documentation: pFMEAs * Basic knowledge in statistics (preferably using Minitab) * Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) * Experience investigating manufacturing operations events in support to product disposition * Experience assessing and tracing manufacturing defects/rejects trends * Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) * Knowledge in Medical Devices regulations * Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence) Skills: * Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists . * Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. * Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. * Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. * Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. * Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. This position is for a Temporary contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers 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 the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Responsibilities: Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develop and implements methods and procedures for inspecting, testing and evaluating products and production equipment. Performs statistical analysis. Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality. Shift: 1st and 2nd shift and weekends (it will depend on production schedule - projects will be executed at different time shifts; sometimes on weekends) Location: Juncos, PR Education: Engineering degree: Mechanical, Electrical or Chemical preferred (not Science) Preferred Qualifications: Experience with Risk management documentation: pFMEAs Basic knowledge in statistics (preferably using Minitab) Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) Experience investigating manufacturing operations events in support to product disposition Experience assessing and tracing manufacturing defects/rejects trends Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) Knowledge in Medical Devices regulations Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence) CAPA/ Investigations/ Root Cause Analyses/Technical Writing Risk Management (pfmea)/Critical Thinking Skills: Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists . Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc

The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global quality processes** across the organization. This role ensures that product quality systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize and enhance processes related to **product quality complaints, deviations, CAPA, and management reporting** , ensuring timely and effective resolution and robust compliance. **Key Responsibilities** + Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for: + Product Quality Complaints + Corrective and Preventive Actions (CAPA) + Deviations + Management Reporting and Trending + Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards. + Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates. + Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation. + Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies. + Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making. + Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence. **Qualifications** Required **Required Qualifications:** + Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred. + Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role. + Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820). + Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes. + Strong analytical and problem-solving skills with a data-driven mindset. + Excellent communication, leadership, and stakeholder management skills. + Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools. + Ability to travel internationally as needed. Preferred + Basic understanding of artificial intelligence and advanced analytics + Experience supporting risk management programs or frameworks. + Familiarity with quality management systems and digital tools. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

For Validation services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering (Preferred Mechanical, Electrical, or Chemical) and five (5) years of experience within the Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Writing and communication skills Shift: 1st, 2nd, and according to business needs. Experience in: CAPA, Investigations, Root Cause Analyses, and Technical Writing. Risk Management (pfmea), Change Control, and Computer Software. Process, Computer validations (not cleaning processes), and Equipment document: URS, FAT, IQ, OQ, PQ. Projects (Design requirements validation, manufacturing controls). The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Develops, modifies, applies, and maintains quality standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develops and implements methods and procedures for inspecting, testing, and evaluating products and production equipment. Performs statistical analysis. Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation, and reliability as they apply to product or process quality. WHO WE ARE: We are a service provider company that is different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Devic,e and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

Provide oversight for the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies, regulatory requirements, and industry standards. Ensure the performance and quality of services conform to established Quality System standards, agency guidelines, and company expectations. Offer expertise and guidance in interpreting regulatory, governmental, and internal quality policies to maintain compliance across operations. Partner with operating entities to analyze processes, ensure requirement alignment, and drive continuous improvement initiatives. Lead audit and inspection preparation activities; support and coordinate during audits; drive resolution of audit and inspection findings. Act as liaison with internal\/external auditing groups and regulatory inspectors throughout the entire audit lifecycle. Coordinate legal and quality documentation requests in support of government investigations or litigations. Maintain and regularly update quality assurance programs, procedures, and documentation to align with evolving standards and regulatory expectations. Promote uniform global quality standards and facilitate best\-practice sharing across sites and teams. Other duties may be assigned. Requirements Minimum of 4 years of relevant experience in the regulated industry. Top 3 Required Experience Areas: Strong investigation skills with demonstrated root cause analysis capabilities. Proficient technical writing, strong organization, and effective communication skills. Experience in Process Validation and Computer Software Validation (CSV). Bachelor's Degree completed with a minimum of 4 years of relevant experience. Master's degree with a minimum of 2 years of relevant experience. *Willing to work 100% on\-Site in Juncos,PR.* "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Manufacturing"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Sr. Quality Systems Specialist","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000017233003","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26ksH07zDXwNYrxh4J3I3qZA\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

The Quality Engineer II will be responsible for supporting validation, risk management, and quality assurance activities in a regulated medical device manufacturing environment. This role requires expertise in validation protocols, statistical analysis, and regulatory compliance, with the ability to work cross-functionally with engineering, manufacturing, and quality teams to ensure product and process excellence. Key Responsibilities Develop, apply, and maintain quality standards and protocols for materials and products at various stages of production. Collaborate with engineering and manufacturing teams to ensure quality standards are established and maintained. Conduct compliant validation processes for equipment, manufacturing processes, and quality information technology systems, including URS, FAT, IQ, OQ, PQ, and TMV. Review and approve validation test plans, reports, and deviations; perform statistical analysis to support validations and product release. Devise and implement inspection and testing methods, procedures, and equipment to ensure product accuracy and compliance. Investigate manufacturing events, defects, and rejects; analyze trends and recommend corrective and preventive actions (CAPA). Lead complaint-handling activities in collaboration with operating unit members. Maintain validation and quality documentation in compliance with applicable federal and international medical device regulations. Perform system administration and configuration of quality information technology systems. Prepare and maintain standard operating procedures (SOPs) for quality systems. Verify and document the effectiveness of CAPA and non-conformance resolutions. Coordinate with domestic and global stakeholders for compliance and quality improvement initiatives. Report on validation activities to fulfill regulatory requirements. Minimum Requirements Bachelor's degree in Engineering (completed) Minimum 3 years of experience in a regulated industry (medical device, pharmaceutical, or related manufacturing). Experience with risk management documentation (pFMEAs). Experience in process validation and equipment qualification (excluding cleaning processes). Knowledge of URS, FAT, IQ, OQ, PQ, and TMV documentation (non-laboratory). Basic to intermediate statistical analysis skills, preferably with Minitab. Knowledge of defining validation strategies from design to manufacturing. Knowledge of Good Manufacturing Practices (GMP) and medical device regulations. Bilingual (English & Spanish - oral and written). Willingness to work 100% on-site. Preferred Qualifications (Nice to Have) Experience with design transfer activities and new product introduction projects. Experience investigating manufacturing events and supporting product disposition. Lean Six Sigma Green Belt Certification. Experience in defect/reject trend analysis. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Project). Familiarity with systems such as SAP, Agile, Compliance Wire, Maximo, MRO Program, TEDS, HR - ABRA Suite, Gallup Online Tool. Strong problem-solving and collaboration skills. Availability to work overtime and weekends when necessary. Work Methodology: Full time contract 100% on-site job in Medtronic-Juncos, PR 6 months of first contract with potential extensions based on performance and budget availability Administrative shift with availability to work non administrative hours or weekends

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers 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 the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Responsibilities: * Responsibilities may include the following and other duties may be assigned. * Develops, modifies, applies and maintains quality standards. * Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develop and implements methods and procedures for inspecting, testing and evaluating products and production equipment. * Performs statistical analysis. * Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality. Shift: 1st and 2nd shift and weekends (it will depend on production schedule - projects will be executed at different time shifts; sometimes on weekends) Location: Juncos, PR Education: Engineering degree: Mechanical, Electrical or Chemical preferred (not Science) Preferred Qualifications: * Experience with Risk management documentation: pFMEAs * Basic knowledge in statistics (preferably using Minitab) * Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) * Experience investigating manufacturing operations events in support to product disposition * Experience assessing and tracing manufacturing defects/rejects trends * Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) * Knowledge in Medical Devices regulations * Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence) * CAPA/ Investigations/ Root Cause Analyses/Technical Writing * Risk Management (pfmea)/Critical Thinking Skills: * Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists . * Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. * Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. * Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. * Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. * Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc