Quality Engineer

Associate, Quality Assurance (QMS)

Java, Kotlin Developer (SSE)

Senior Project Manager Engineer

Finance Controller

Manager, Site Logistics & Project Integration

Digital Factory Engineer

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Responsibilities: Provide review and drive to approval of the validation protocols and reports for facility, equipment, laboratory instrument, and utility systems. <ul><li>Review and approval of technology/method transfer protocols and reports.</li><li>Review and evaluation of change controls</li><li>Review and approval of deviations and assurance that they define root causes and determine appropriate CAPA.</li><li>Participate in cross-functional teams to support execution of commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and validation protocols.</li><li>Provide quality presence during qualification execution, ensuring data integrity, deviation management, and proper documentation of results.</li><li>Support the timely review and approval of executed qualification documentation and ensure readiness for inspection or submission.</li><li>Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing validation, change control, deviation, and other SOPs relevant to the responsibilities</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Ensure proper execution of Good Documentation Practices (GDP) in all QA-reviewed documents, including validation records, logbooks, and manufacturing records.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits, with emphasis on operational and qualification-related topics.</li><li>Monitor key quality metrics and drive performance improvements in areas such as deviation reduction, batch record right-first time, and qualification readiness.</li><li>Contribute to the continued inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in engineering or technical discipline (e.g., engineering, Biology, Chemistry, Pharmacy).</li><li>5+ years of experience in pharmaceutical manufacturing QA, including direct involvement in qualification/validation activities.</li><li>Prior experience reviewing or approving qualification protocols and validation reports in GMP environments.</li><li>Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.</li><li>Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.</li><li>Experience supporting regulatory inspections and validation documentation reviews.</li></ul> Skills/Competencies <ul><li>Strong knowledge of validation principles and qualification documentation expectations.</li><li>Effective team leader with experience supervising QA staff and coordinating cross-functional support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders.</li><li>Sound judgment and decision-making under pressure in a dynamic manufacturing environment.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

Role Description: <ul><li>The Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site.</li><li>This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment.</li></ul> Responsibilities: <ul><li>Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints.</li><li>Support the preparation and tracking of quality metrics and trending reports.</li><li>Help coordinate internal audits and document audit responses.</li><li>Participate in documenting product quality complaints and adverse event records.</li><li>Aid in digitizing logbooks and checklists using electronic systems.</li><li>Collaborate with cross-functional teams to ensure timely and accurate documentation updates.</li><li>Provide administrative support for change control processes and quality-related meetings.</li><li>Assist in preparing documentation for regulatory inspections and external audits.</li><li>Maintain document control systems and ensure timely review and archival of QA records.</li><li>Support training documentation and tracking for QA-related procedures.</li><li>Help with data entry and analysis for quality reports using basic statistical tools.</li><li>Monitor document lifecycle and ensure version control compliance.</li><li>Participate in continuous improvement initiatives related to documentation and QMS processes.</li></ul> Requirements: Education &amp; Experience <ul><li>Required Education: Bachelor’s degree in Pharmaceutical Sciences or a related field.</li><li>Preferred Education: Master’s degree is a plus.</li><li>Experience: 1–3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable).</li><li>Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred.</li></ul> Physical Requirements <ul><li>On-site role at Chestnut Ridge, NY.</li><li>Standard work hours: 8 AM to 5 PM.</li><li>No travel required.</li><li>No lifting or driving responsibilities.</li></ul>

Responsibilities: <ul><li>Develop and maintain robust and scalable backend services primarily using Kotlin and Ktor.&nbsp;</li><li>Engage in architectural discussions and contribute to the design of a multi-regional backend.&nbsp;</li><li>Maintain and manage SQL and NoSQL databases.&nbsp;</li><li>Integrate with search clusters such as OpenSearch.&nbsp;</li><li>Work on our payment &amp; product platform and ensure fault tolerance.&nbsp;</li><li>Manage deployments with tools like GitHub, Gradle &amp; CircleCI.&nbsp;</li><li>Monitor built services directly in the cluster and through services such as Sentry and Datadog.&nbsp;</li><li>Mentor junior engineers, guiding them on best practices.&nbsp;</li></ul> Requirements: <ul><li>7+ years of professional backend engineering experience.&nbsp;</li><li>3+ years of developing in Kotlin, with extensive understanding of modern and asynchronous backend frameworks.&nbsp;</li><li>Worked with Kafka or a similar event streaming platform&nbsp;&nbsp;</li><li>Fluent in Git, CI/CD, and build automation.</li><li>Knowledge of how to deploy, ingress, monitor, and manage backend services in a Kubernetes cluster.&nbsp;</li><li>Excellent communication skills and ability to explain technical concepts to non-technical stakeholders.&nbsp;</li></ul>

Responsibilities: <ul><li>Take full ownership of one or more New Product Development (NPD) projects.</li><li>Lead core teams toward achieving common project objectives.</li><li>Manage project resources effectively to ensure projects are “staffed for success.”</li><li>Collaborate and negotiate with functional managers and the Project Approval Committee (PAC) to address and resolve resource constraints.</li><li>Ensure adherence to the defined product development process and maintain project discipline.</li><li>Keep the team focused on priorities and individual responsibilities.</li><li>Present regular project status updates to the PAC following the contract date.</li><li>Proactively identify risks and drive timely actions to maintain project momentum.</li><li>Resolve conflicts and manage controversial issues constructively.</li></ul>&nbsp;Requirements: Qualifications &amp; Experience <ul><li>Education: Bachelor’s degree required.</li><li>Experience: 5–10 years of experience in project management or a related field.</li><li>Industry Experience: Manufacturing experience is required.</li><li>Proven leadership skills in developing and managing cross-functional teams.</li><li>Demonstrated ability to create effective project plans, manage risks, and handle uncertainties.</li><li>Solid understanding of project management techniques, tools, and best practices.</li><li>Knowledge of manufacturing processes and operations.</li><li>Experience working in a matrix organization and navigating cross-functional dynamics.</li><li>Expertise in balancing time-to-market goals with quality commitments.</li><li>Strong critical thinking, problem-solving, and decision-making skills.</li><li>Excellent verbal communication skills (English proficiency required).</li><li>Certifications: Qualification in Project Management or equivalent; PMP certification preferred.</li></ul>

Responsibilities: <ul><li>Management of finance team to ensure delivery of timely, accurate monthly accounts, preparation of the financial pack and KPIs.</li><li>The key focus will be to drive financial and business improvements in the Filter Products manufacturing site and to act as a business partner to the local GM and management team.</li><li>Support is also required for the local Distribution business.</li><li>Review site month end financials, prepare variance analysis with supporting commentary consolidate for the Hungary region.</li><li>Drive site Gross margin and Non-productive spend initiatives.</li><li>Prepare and review customer and product analysis (pricing, revenue and margin).</li><li>Drive working capital improvements including cash collection and inventory management.</li><li>Ensure that standard costs are maintained and implemented across the product range in the Filter Products manufacturing site.</li><li>Review site control files and trial balances to ensure no financial risk to the business and instil robust financial controls.</li><li>Ensure that all sites comply with the Filtrona Accounting Manual (EAM).</li><li>To support the businesses in the preparation of the annual Plan and quarterly forecasts for the region and associated presentations and packs.</li><li>Review of all capex appraisals pre sign off and follow up on actual spend v plan.</li><li>Attend and present the financials at the monthly operational reviews.</li><li>Legal and banking signatory for the Filter Products business and sign off monthly payroll run.</li><li>Review monthly FX hedging forecasts and submissions to Group Treasury</li><li>Deal with Group, SBU and Regional FD requests</li><li>Lead the preparation for the Hungarian internal and external audits.</li><li>Develop staff and identify training needs within the team. Document standard procedures.</li><li>Keeping the HSE-, fire safety- and hygiene rules, wearing the relevant personal protective equipment.</li><li>During the daily work meeting the expectations of the Integrated Management System regulations.</li></ul> Requirements: <ul><li>Educated to degree level (potentially in Finance, Accounting, or Economics); professional accounting qualification.</li><li>10 years PQ experience within a manufacturing environment is essential.</li><li>High level of numeracy and IT literate (Excel/PowerPoint).</li><li>Excellent English written and oral communication skills.</li><li>Audit background</li><li>ERP system knowledge</li><li>Project management knowledge and experience</li></ul>

Responsibilities: Warehouse &amp; Materials Management <ul><li>Oversee all warehouse activities including receiving, storage, handling, and internal material movement to ensure compliance with cGMP, DEA, and safety regulations.</li><li>Develop and maintain systems for inventory management, accuracy, and traceability, including raw materials, components, packaging, and finished goods.</li><li>Ensure timely and compliant movement of materials to support production schedules and product release timelines.</li><li>Collaborate with Quality and Compliance teams to maintain cGMP storage practices, support inspections, and ensure readiness.</li></ul> Planning &amp; Supply Coordination <ul><li>Lead the site’s production and materials planning processes to ensure timely availability of materials and resources to meet manufacturing demands.</li><li>Manage and optimize the site’s Master Production Schedule (MPS), material requirement planning (MRP), and capacity planning tools.</li><li>Coordinate with corporate Supply Chain and Procurement functions to align site planning with supplier performance and external manufacturing dependencies.</li></ul> Project Management &amp; Integration <ul><li>Serve as a site-level project manager for cross-functional initiatives including new product introductions (NPIs), facility readiness, equipment onboarding, and continuous improvement projects.</li><li>Develop project timelines, resource allocations, risk assessments, and stakeholder communication plans to ensure successful project execution.</li><li>Support greenfield and expansion activities by coordinating logistics, materials, and equipment staging activities.</li></ul> Systems &amp; Process Development <ul><li>Lead implementation and optimization of ERP and warehouse management systems to enable efficient and compliant operations.</li><li>Develop and implement SOPs, training programs, and KPIs across warehouse and planning functions.</li><li>Identify opportunities for process automation, waste reduction, and continuous improvement in site logistics operations.</li></ul> Requirements: Qualifications / Experience: <ul><li>Bachelor’s degree in Supply Chain, Engineering, Business, Operations Management, or related field.</li><li>7+ years of progressive experience in warehouse, planning, or project management roles within pharmaceutical or highly regulated industries.</li><li>Strong understanding of cGMPs, DEA requirements for controlled substances, and sterile manufacturing logistics.</li><li>Proven experience implementing ERP systems (SAP, Oracle, etc.) and managing warehouse or supply chain digital tools.</li><li>PMP certification or formal project management training strongly preferred.</li></ul> Skills/Competencies: <ul><li>Strong organizational, analytical, and problem-solving skills.</li><li>Effective leadership and team-building abilities across cross-functional stakeholders.</li><li>Proficiency in project management tools and planning systems.</li><li>Excellent verbal and written communication with the ability to influence at all levels.</li><li>High sense of ownership, attention to detail, and adaptability in a fast-paced, startup environment.</li><li>Commitment to compliance, quality, and patient-centered operations.</li></ul>

Responsibilities: <ul><li>At our client, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.&nbsp;</li><li>Drives the implementation of programs and projects to improve products and processes and develops deployment plans.&nbsp;</li><li>Digital Factory transformation project followed APAC and Internal plant.direction.&nbsp;</li><li>Daily trouble shooting in production, provide short term &amp; long term solution to team.&nbsp;</li><li>Suggest &amp; drive improvements digital solution.&nbsp;</li><li>Support project assignment.&nbsp;</li></ul> Requirements:&nbsp; <ul><li>Plant digitals, cooperate with APAC and our client service team for transformation project.&nbsp;</li><li>Digital factory transformation project implementation, Identify and resolve issue during implementation.&nbsp;</li><li>Training on new digital tools and technologies. Develop training material and provide training to ensure fully utilization.&nbsp;</li><li>Maintain and troubleshooting for exiting digital tools, AGV, Material Calling System, Hydra, dPIM etc.&nbsp;</li><li>Continuous Improvement, identify new opportunities and innovation in operation processes.&nbsp;</li><li>Data analysis and monitoring, Operations Scorecard, Operation Dashboard (SCCOP, SHE, OEE) and advise weakness areas for improvement.&nbsp;</li><li>Handle on CER related /CI working with operations and cross functional team.&nbsp;</li><li>Support operations project assignment.&nbsp;</li></ul> What your background should look like&nbsp; <ul><li>Bachelor’s Degree in Information Technology, Computer science or related field.&nbsp;</li><li>Strong knowledge and experiences in Digital transformation projects.&nbsp;</li><li>Familiarity with digital tools and technologies used in manufacturing.&nbsp;</li><li>Minimum 3 to 6 years working experience in manufacturing sector.&nbsp;</li><li>Knowledge of in cloud technology, virtualization, mobile application, IOT, SQL Server.&nbsp;</li><li>Reporting Services, Power BI, Tableau.&nbsp;</li><li>Good knowledge in Data Storage, Cloud, Microsoft Power Apps.&nbsp;</li><li>Good knowledge in Dashboard creation, Graphic and User Interface (UI) design.&nbsp;</li><li>New enhancement for new functionality in SAP and Hydra.&nbsp;</li><li>OEE, Utilization analysis skill.&nbsp;</li><li>Knowledge and experiences in Enterprise Resource Planning software – SAP/BOM/Routing will be advantage.&nbsp;</li><li>Logical thinking with Project Management Skill.&nbsp;</li><li>Fluent in English and good communication.&nbsp;</li><li>Interpersonal skills.&nbsp;</li></ul>

Responsibilities: <ul><li>Support bulk cable team by tracking quality, compiling reports, assist with DOEs and product qualification</li><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Implement quality planning and controls for prototype and/or sample builds.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Coordinate sample preparation and certification for product verification and qualification testing.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool Approval Report (CTAR).</li><li>Collaborate with MPDE, monitor process capability/data and oversee ongoing corrective actions as required.</li><li>Collaborate with corporate UL team / UL engineer/PJE/PQE for new certification. -Collaborate with PDE, analyze physical/SI data and make qualification report.</li><li>Collaborate with PDE, CA PDE/SI/MPDE, support SQE on outsourced cable quality control and improvement from bulk cable engineering side.</li><li>Preparation for prototype/sample making: -Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Data Analysis:Monitor process physical/SI data.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Review 108 and finish 501 documents per customer requirement and industrial standards.</li><li>Coordinator during prototype/sample making: -Monitor process capability and oversee ongoing corrective actions as required.</li><li>Support MPDE on FACA.</li><li>Support PDE on design improvement.</li><li>Coordinator during outsourced cable qualification process:Review outsourced cable Physical data, SI data, Reliability data, stability data, give comments from bulk cable engineering side on supplier quality and product quality.</li></ul> Requirements:﻿ <ul><li>Bachelors or Masters Degree in science or technology.</li><li>10 years min. working experience in bulk cable design or manufacturing.</li><li>3 years team management experience.</li><li>Familiar with bulk cable knowledge, bulk cable manufacturing knowledge and machines knowledge.</li><li>Can work under the pressure.</li><li>Drive for results, good problem solving skills</li><li>Good communication skill, integrity, accountability and passion, Integrity, ccountability, team work</li><li>Good communication, interpersonal and management skills</li></ul>

Responsibilities: <ul><li>Collaborate with engineering, production, and planning teams to continuously improve product quality across the manufacturing process.</li><li>Supervise and manage the incoming and final inspection areas.</li><li>Drive improvement initiatives within incoming, in-process, and final inspection operations.</li><li>Prioritize inspection activities to ensure timely completion of production materials, engineering validations, and gage R&amp;Rs.</li><li>Identify and execute containment actions for nonconforming materials found during in-process or final inspections.</li><li>Work with cross-functional teams to investigate nonconforming products using root cause analysis tools (Ishikawa, 5-Whys, Is-Is Not, etc.) and implement corrective and preventive actions.</li><li>Communicate with customers regarding product-related complaints and facilitate evaluation and return of materials as needed.</li><li>Investigate product quality issues related to customer returns (e.g., nonconforming material reports, corrective actions).</li><li>Create and update operations procedures and documentation used within production.</li><li>Ensure compliance with quality assurance policies and procedures to meet or exceed customer expectations.</li><li>Implement continuous improvement initiatives to reduce defects, improve efficiency, and enhance product quality.</li><li>Conduct manufacturing and quality system audits to ensure compliance with ISO 13485.</li><li>Support operational projects such as Kaizen, data analysis, and problem-solving initiatives.</li></ul> Requirements: Qualifications/Background: <ul><li>Bachelor’s degree in Quality, Science, or Engineering preferred (High School Diploma with equivalent experience will be considered).</li><li>Prior experience as a Quality Engineer in a manufacturing environment.</li><li>5+ years of industry experience in a medical device manufacturing or pharmaceutical environment.</li><li>Supervisory or management experience preferred.</li><li>Working knowledge of FDA, ISO, and MDD quality systems applicable to medical device companies.</li><li>Excellent written and verbal communication skills.</li></ul>

Responsibilities: <ul><li>Act as a single-point-of-contact for topics and issues related to supplier quality within the Heredia, Costa Rica facility.</li><li>Lead supplier-related activities to ensure incoming quality is proactively planned, prepared, and ensured in advance before production part is approved and released.</li><li>Continually improve supplier performance through coaching, training, consequence enforcement, supplier awards and motivation, supplier restriction and disqualification, etc.</li><li>Measure and communicate supplier performance to those suppliers and the organization.</li><li>Evaluate, qualify, approve appropriate new, competitive suppliers (including search for new suppliers), in collaboration with the procurement teams.</li><li>Review and approve/reject/amend supplier Production Part Approval Process (PPAP) submissions for new product releases and qualifying changes to existing components.</li><li>Monitor quality data within the operating systems to ensure data accuracy and develop reporting systems to accurately document and record supplier trends and performance.</li><li>Periodically monitor quality specifications to ensure supplier compliance.</li><li>Work with engineering to clarify and change specifications regarding incoming goods when necessary.</li><li>Clearly communicate (and enforce) company requirements and expectations to suppliers.</li><li>Solicit, drive, monitor, review, approve, and validate containment/corrective/preventive actions by suppliers.</li><li>Facilitate supplier quality roadmaps leading to improved supplier performance.</li><li>Conduct process and system audits of suppliers and maintain working knowledge of ISO and TS quality system requirements.</li><li>Serve as Supplier Quality Lead / SME during internal audits and 3rd party inspections/audits (FDA, BSI).</li><li>Chair QBRs (Quarterly Business Reviews) with key suppliers.</li><li>Validate manufacturing and supplier processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).</li><li>Interact with cross-functional teams to resolve supplier-related quality issues.</li></ul> Requirements: Qualifications &amp; Background: <ul><li>Bachelor’s degree in Process Engineering, Manufacturing Engineering, or other engineering discipline plus 5+ years’ experience in a manufacturing environment.</li><li>Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) – ISO 13485 and ISO 14971.</li><li>Bilingual (English / Spanish).</li><li>Experience in a Supplier Management role.</li><li>Experience conducting quality audits in a manufacturing environment.</li><li>Lean Six Sigma Green Belt Certification.</li><li>Proficiency in Microsoft Office.</li><li>Strong problem-solving and analytical skills for compiling and analyzing data.</li><li>Knowledge of DOE, SPC, Gage R&amp;R, and sampling plans.</li><li>Effective time management skills, applied to fast-moving and high-pressure environments.</li><li>Ability to work independently with little or no supervision, as well as in teams.</li><li>Willingness to travel (approximately 10%) to visit suppliers.</li></ul>

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139 inspection tools Jobs found

Quality Engineer

Associate, Quality Assurance (QMS)

Java, Kotlin Developer (SSE)

Senior Project Manager Engineer

Finance Controller

Manager, Site Logistics & Project Integration

Digital Factory Engineer

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

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139 inspection tools Jobs found

Quality Engineer

Associate, Quality Assurance (QMS)

Java, Kotlin Developer (SSE)

Senior Project Manager Engineer

Finance Controller

Manager, Site Logistics & Project Integration

Digital Factory Engineer

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

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

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