Senior Quality & Reliability Engineer

Finance Business Partner

Senior Project Management Engineer

C# Developer (SSE)

Junior Scrum Master

Senior Microbiology Technician

Project Manager Engineer

Service Delivery Manager

Manager II – Quality & Reliability Engineering

MPDE Technician

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: <ul><li>The Finance Business Partner, Operations will be providing timely, relevant and accurate information and insightful analysis to facilitate decision-making of senior management.</li><li>Developing the capability to drive swift data extraction and visualization bringing visibility and transparency of key business metrics.</li><li>Focused on finding meaningful insights to support continued and sustainable profitable growth of the our client business.</li><li>Drive improvement in the conversion cost and site fixed overhead vs budget and historical periods.</li><li>Also, bringing actionable insights, identity focus areas and run simulations for site management to optimize the cost level, in line with forecasted business activity.</li><li>Need monthly tracking and action monitoring, working collaboratively with site teams across different functions, and create visibility with global manufacturing team on the improvement actions.</li><li>Drive digital transformation journey of finance function and be instrumental in increasing utilization of BI tools, especially Power BI.</li><li>To include developing the dashboards and power query models required to achieve efficiency in data extraction and visualization.</li><li>Understand diverse internal and external data source and its architecture.</li><li>Able to integrate various data source for seamless automation of business analysis resulting in optimization of core financial workflows, enhancing efficiencies.</li><li>Able to perform analysis using large complex dataset, enhance the reports to improve performance tracking against targets and trend identification.</li><li>Effective contribution in annual budgeting and monthly forecasting process, such as developing templates for end-to-end budget planning and forecasting process.</li><li>Build and foster strong cross-functional relationships across business constituencies and stakeholders specially group support functions like Supply Chain, Manufacturing Ops and Procurement. Help the company understand how the pieces fit together to drive performance and strengthen the team’s partnership and influencing skills in pursuit of growth.</li><li>Price, Mix and Volume Analysis for Margin Improvements</li><li>Proactive participation in various business improvement/ad hoc projects.</li><li>Manages the overall Financial Reporting and Analysis activities in the production and delivery of all standard reporting (including template and chart updates), ad hoc reporting, presentation materials; and non-pricing / profitability (costing) analysis for the business, in accordance with defined standards.</li></ul> Requirements: <ul><li>At least 8-10 years’ work experience in Finance with at least 6 years’ experience in FP&amp;A</li><li>Experience working in manufacturing environment is a must</li><li>Strong business acumen.</li><li>Strong financial, technical, and quantitative analytical skills</li><li>In-depth knowledge of accounting principles, practices and regulatory issues and their application to a wide variety of areas</li><li>Ability to take ownership of a task or process, and see it through from inception to completion</li></ul> Preferred Skills <ul><li>Proven track record of developing and implementing value-added financial analysis</li><li>Self-awareness and ability to handle tight deadlines and manage complex business challenges</li><li>Demonstrated experience in analyzing and synthesizing complex financial data into meaningful executive summary statements</li><li>Excellent verbal and written skills, analytical thinker / problem solver, interpersonal skills, attention to details</li><li>Advance Excel skill, MS office and data management, Power BI skill is added advantage</li></ul> Key Relationships with Internal and External Stakeholders <ul><li>Operational Leadership</li><li>Site Finance Controllers</li><li>Group Finance Team</li><li>Site GMs and Operation team</li></ul> Additional Notes <ul><li>Sound financial knowledge with Chartered Accountant background</li></ul>

Responsibilities: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multigation plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to assure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years experience in connector/cable/cable assembly is better</li></ul>

Responsibilities: <ul><li>Develop distributed system architecture and system integration&nbsp;&nbsp;</li><li>Design event-driven applications leveraging microservices architecture on cloud platform&nbsp;</li><li>Carry out Model and assess complex IT solutions&nbsp;&nbsp;</li><li>Work closely with platform engineers and other IT professionals to choose compatible design solutions&nbsp;</li><li>Manage and comply with release management process&nbsp;</li><li>Analyze the scope and expected organizational impact of information systems&nbsp;</li><li>Evaluate existing systems and provide advice on how to meet organizational requirements&nbsp;</li><li>Ensure that the technical components of the project are in sync with the business needs of the organization&nbsp;</li><li>Ensure that information systems are secure from threat&nbsp;</li><li>Provide advice on project design, project costs, and expected benefit&nbsp;</li><li>Identifies technical debt and proactively recommends alternatives or improvements&nbsp;</li></ul> Requirements: <ul><li>University degree in Computer Science, Computer Engineering or related subjects preferred&nbsp;&nbsp;</li><li>8+ years of work experience building applications&nbsp;</li><li>Advanced understanding of IT infrastructure and enterprise architectures&nbsp;</li><li>Proven experience with microservices-based architecture&nbsp;</li><li>Proficiency in coding with modern programming languages such as C#, Python, or Node.js&nbsp;</li><li>API-first development experience&nbsp;</li><li>Experience with Cloud Computing (Azure preferable)&nbsp;</li><li>Extensive expertise in any modern document-oriented database, with a preference for MongoDB&nbsp;</li><li>Experience in developing components for Event-Driven Architecture, with a minimum of production-level experience using Event Hubs or Event Grid (or similar technologies like Kafka)&nbsp;</li><li>Experience working in an agile environment with a focus on engineering practices like testing, continuous integration, etc.&nbsp;</li><li>Good knowledge of virtualization&nbsp;&nbsp;</li><li>Analytics mindset with critical thinking and problem-solving skills&nbsp;</li><li>Fine knowledge of industry trends and emerging technologies&nbsp;</li><li>Fluent in English&nbsp;</li></ul>

Responsibilities: <ul><li>Coordinate cross-functional activities to ensure project milestones are met on time and within scope.</li><li>Facilitate Agile ceremonies such as daily stand, sprint planning, retrospectives, and demos.</li><li>Collaborate with Product Owners, Business Analysts, and Technical Leads to refine requirements and ensure team alignment.</li><li>Track and report on project progress, risks, and dependencies using tools like Azure DevOps, JIRA, Confluence, or equivalent.</li><li>Identify and resolve roadblocks, escalating issues when necessary to ensure continued progress.</li><li>Support project documentation including project plans, timelines, meeting notes, and status reports.</li><li>Assist in backlog grooming and user story definition to ensure readiness for development.</li><li>Foster a positive and productive team environment by promoting collaboration, accountability, and transparency.</li></ul> Requirements: <ul><li>2+ years of experience in a Project Coordinator and/or Scrum Master role.</li><li>Familiarity with Agile methodologies and tools (e.g., JIRA, Confluence, Azure DevOps).</li><li>Strong organizational skills with the ability to manage multiple priorities and projects.</li><li>Excellent verbal and written communication skills, with the ability to interface effectively with both technical and non-technical stakeholders.</li><li>Detail-oriented and proactive, with a focus on driving results and continuous improvement.</li><li>Experience preparing project documentation and facilitating team meetings.</li></ul>

Responsibilities: <ul><li>Perform and oversee complex microbiological activities, including environmental monitoring (viable and non-viable), utility sampling (e.g., water, compressed gases), and aseptic process support in areas utilizing isolator technology.</li><li>Conduct and review microbiological testing for bioburden, endotoxin (LAL), sterility, and microbial identification on raw materials, in-process samples, and final products.</li><li>Support and lead aspects of aseptic process simulations (media fills) including planning, execution, incubation, and interpretation of results within isolator systems.</li><li>Assist in the startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.</li><li>Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.</li><li>Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.</li><li>Mentor and provide technical guidance to junior microbiology staff, fostering a culture of scientific excellence, compliance, and continuous learning.</li><li>Maintain laboratory readiness for internal and external audits by following and enforcing good laboratory practices and cGMP expectations.</li><li>Participate in ongoing improvements to laboratory procedures, contamination control strategies, and sterility assurance programs.</li><li>Interface cross-functionally with Quality Assurance, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion activities.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>Minimum of 3-5 years of microbiology laboratory experience in a cGMP pharmaceutical or biotechnology manufacturing environment.</li><li>Experience with isolator-based sterile manufacturing processes and aseptic support activities is strongly preferred.</li><li>Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li><li>Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.</li><li>Prior experience with high potent APIs and/or controlled substances is desirable.</li></ul> Skills/Competencies: <ul><li>Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.</li><li>Strong documentation and data integrity skills with a meticulous attention to detail.</li><li>Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.</li><li>Effective time management and prioritization skills in a fast-paced environment.</li><li>Strong communication skills with the ability to train and mentor junior staff.</li><li>Proactive, collaborative, and compliance-oriented mindset.</li><li>Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.</li></ul>

Responsibilities: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multination plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to ensure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with the Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor’s degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years’ experience in connector/cable/cable assembly is better</li><li>Fluent oral and written/reading in English</li><li>Experience in IT Project Manager, Data Center Business or digital networking project is an advantage.</li></ul>

Responsibilities: Manage Relationship with business on Run service: <ul><li>In charge of Run activities for applications or services and conduct business review with business representatives</li><li>Manage escalation from business teams and ensure business continuity and follow till closure</li><li>Manage dependencies and trigger hierarchical escalation protocol as needed ("pending by user, awaiting vendor status" tickets etc.)</li><li>Own critical outbound communications from IT with business</li><li>Conduct or collaborate with BRM for demand management for minor evolutions in alignment with build teams</li><li>Track and ensure business satisfaction and take necessary action to improve CSAT progressively</li><li>Contribute to larger community of SDM and ITSM Process Owner.</li><li>Onboard other scope into service as the organization is moving to Platform organization.</li></ul> Monitor and control service delivery: <ul><li>Take ownership of major incidents, ensuring coordination of resolving parties, effective communication to stakeholders and post incident review</li><li>Review ticket backlog (especially aging tickets) on regular basis and prioritize as per SLA commitments when applicable</li><li>Track, analyze and report metrics (SLA and KPI) and take corrective actions as needed for service excellence</li><li>Work with Application management service partner to generate actionable insights to improve system availability and performance</li><li>Ensure Knowledge Mgmt. and build to run practices are followed and regularly conduct audits</li><li>Recommend, monitor, and ensure continuous improvement activities are delivered by AMS teams</li><li>Increase the ITIL compliance for all services delivered by teams (incident, problem, change.)</li><li>Review global process KPIs using power BI dashboard for process excellence and draft process improvement suggestions</li><li>Lead change management including process governance, CAB &amp; quality control.</li></ul> Requirements: <ul><li>High level of business orientation</li><li>Proactive and process mindset</li><li>Solid IT process knowledge with very good ITIL understanding</li><li>Practical knowledge and experience on IT process development and service roll outs</li><li>Strong experience in supplier collaboration with offshoring model (located in India)</li><li>Demonstrated ability to communicate effectively with different stakeholders (both written and oral).</li><li>Ability to operate in a large and complex organization which is transformation to become more professional.</li><li>Strong Change Management skills</li><li>Excellent problem solving &amp; team collaboration skills</li><li>Experience on SAP function modules (FICO, SD, MM, WM)</li><li>Proven 6+ years working experience as an IT service delivery manager or coordinator</li><li>Knowledge of IT Service Management ITIL EXPERT certification will be appreciated)</li><li>Proven track record in IT/IS Project Management (PMI, Prince 2 certification will be appreciated) including coordination of various teams and service providers</li><li>Experience on SAP (SRM, ABAP, GRC)</li><li>Proficiency in using ServiceNow, PowerBI</li></ul>

Responsibilities: <ul><li>Lead development and execution of standardized DfRE and RV methodologies across Converged Products.</li><li>Champion a Design for Six Sigma (DFSS) culture, mentoring and training product design teams.</li><li>Oversee product validation, including HALT/HAST testing, Test-to-Failure (TTF) methodologies, and DOE approaches.</li><li>Collaborate with Product Development Engineering (PDE), Manufacturing Process Development Engineering (MPDE), Field Application Engineering (FAE), and Advanced Quality Engineering (AQE) teams to integrate reliability considerations throughout the product lifecycle.</li><li>Develop comprehensive test and validation plans aligned with our client LeanPD stage-gate approach.</li><li>Drive early concept testing, failure mode identification, and iterative product design improvements.</li><li>Support failure analysis (F/A), Root Cause and Corrective Action (RCCA), and competitive benchmarking activities.</li><li>Partner with Global R&amp;T COE to develop custom test equipment, test systems, and software for unique testing requirements.</li><li>Manage and coach a high-performing team, ensuring clear accountability, skill development, and work-life balance.</li></ul> Requirements: <ul><li>Bachelor’s or Master’s degree in Electrical Engineering, Electronics, or Mechatronics.</li><li>10+ years of experience in all aspects of reliability engineering for electronic or mechatronic products (reliability estimation, calculation, and risk identification).</li><li>Extensive experience with test equipment, test systems, labs, HALT/HAST testing, validation plans, and custom test systems.</li><li>Proven experience working with global, cross-functional engineering teams in multi-site organizations.</li><li>Strong analytical, critical thinking, and problem-solving skills.</li><li>Knowledge of FIT estimation methodology, Weibull/Chi-Square statistical analysis, FMEDA, FTA, and Bayes theorem applications.</li><li>Reliability engineering training from ASQ, TUV, Reliasoft, or equivalent.</li><li>Excellent written and verbal communication skills in English.</li><li>Willingness to travel up to ~20%.</li></ul>

Responsibilities: Prototype Build and Trial Production Support: <ul><li>Participate in new product development projects, responsible for the fabrication, assembly, and preliminary testing of prototypes, ensuring timely delivery of samples required for design verification.</li><li>Support small-batch trial production (NPI) activities; operate equipment according to trial process plans, execute production processes, and accurately record various parameters and data during trial production.</li><li>Assist engineers in setting up and debugging temporary production lines or jigs and fixtures required for trial production, and participate in the on-site acceptance and debugging of new equipment and tooling, providing feedback from an operators perspective.</li></ul> Production Issue Identification and Preliminary Analysis: <ul><li>During prototype building and trial production, closely monitor and meticulously document all process, assembly, equipment, or material issues (e.g., assembly interference, performance deviation, equipment instability).</li><li>Conduct preliminary analysis of problems based on hands-on experience, providing engineers with detailed observations and firsthand descriptions to assist in root cause analysis.</li></ul> Process and Documentation Assistance: <ul><li>Based on hands-on trial production experience, assist engineers in developing, optimizing, and creating necessary process documentation for both trial and mass production, including but not limited to:</li><li>Standard Operating Procedures (SOPs)</li><li>Equipment Operation Manuals</li><li>Equipment Daily Check and Maintenance Plans</li><li>Ensure the practicality and usability of process documentation to lay a solid foundation for subsequent mass production.</li><li>Participate in trial production reviews, providing feedback on process optimization from an operators viewpoint.</li></ul> Production Transfer and Knowledge Handover: <ul><li>Play a key role in transferring process and operational knowledge to the mass production team during the transition from trial to mass production.</li><li>Participate in training mass production operators, ensuring they master the correct operating methods and quality control points for the new product.</li></ul> Requirements: <ul><li>Vocational school, technical school certificate, or associate degree in Mechanical, Electronic, Automation, Mechatronics, or other related engineering fields.</li><li>Experience Requirements</li><li>Typically requires 1-3 years of experience in manufacturing. Preference given to those with experience in New Product Introduction (NPI), prototype building, trial production support, or as an R&amp;D assistant.</li><li>Familiarity with product development processes is preferred.</li></ul>

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27 scope identification Jobs found

Senior Quality & Reliability Engineer

Finance Business Partner

Senior Project Management Engineer

C# Developer (SSE)

Junior Scrum Master

Senior Microbiology Technician

Project Manager Engineer

Service Delivery Manager

Manager II – Quality & Reliability Engineering

MPDE Technician

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27 scope identification Jobs found

Senior Quality & Reliability Engineer

Finance Business Partner

Senior Project Management Engineer

C# Developer (SSE)

Junior Scrum Master

Senior Microbiology Technician

Project Manager Engineer

Service Delivery Manager

Manager II – Quality & Reliability Engineering

MPDE Technician

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.