Quality & Reliability Technician

Document Controller

Staff Advanced Quality Engineer (Software)

Associate, Quality Assurance (QMS)

124480 Quality System Engineer

Responsibilities: <ul><li>Testing &amp; Inspection: Conduct dimensional, mechanical, and electrical tests on incoming components, prototypes, and finished products (e.g., connectors and sensors).&nbsp;</li><li>Data Management: Record test results, prepare statistical performance reports, and analyze data for quality trends.&nbsp;</li><li>Quality Compliance: Assist in audits, maintain Quality Management System (QMS) documentation, and ensure adherence to standards like ISO 9001 and IATF 16949.&nbsp;</li><li>Problem Solving: Facilitate Root Cause Analysis (RCA), raise Non-Conformance Reports (NCRs), and support corrective action implementations.&nbsp;</li><li>Collaboration: Act as a liaison between production, engineering, and quality teams to troubleshoot issues and improve processes.&nbsp;</li></ul> Requirements: <ul><li>Education: Diploma in Engineering (e.g., Electrical, Mechanical) or an Associates degree/relevant vocational qualification.</li><li>Experience: Typically requires 2 to 5+ years of hands-on experience in a manufacturing, quality, or testing environment (often dealing with automotive or electronic assemblies).</li><li>Technical Skills: Familiarity with test equipment (e.g., microscopes, multimeters, Universal Testing Machines), blueprint reading, and Geometric Dimensioning and Tolerancing (GD&amp;T).</li><li>Core Tools: Understanding of core quality methodologies such as 8D, FMEA, and SPC.&nbsp;</li></ul>

Role Description : <ul><li>This role supports project teams by controlling documentation for EPC projects—identifying, uploading and distributing engineering deliverables and maintaining electronic and hardcopy repositories with accurate indexing, revision control, metadata and access permissions.</li><li>It operates EDMS (SharePoint, ProjectWise), manages the change control lifecycle (issue/revise/approve/distribute/archive) and reviews documents for completeness and contractual/QMS compliance.</li><li>The role maintains traceability, transmittals and audit trails, prepares reports, supports technical reviews and handovers, follows up on pending reviews, and safeguards data integrity and confidentiality.</li><li>Control all documentation activities: identify, upload and distribute engineering deliverables.</li></ul> Responsibilities: <ul><li>Maintain electronic and hardcopy repositories with accurate indexing, revision control and retrieval.</li><li>Operate and administer EDMS (SharePoint, ProjectWise, etc.): uploads, metadata, permissions and folder structures.</li><li>Review drawings, specifications, change orders, submittals and vendor documents for completeness, format and contractual/QMS compliance; resolve discrepancies.</li><li>Manage the change control lifecycle: issue, revise, approve, distribute, archive and retire controlled copies.</li><li>Ensure documents are correctly dated, versioned and authorized prior to release.</li><li>Maintain traceability registers, revision histories, distribution lists, transmittals and audit trails.</li><li>Prepare transmittals, distribution notices, status updates and ad?hoc project reports.</li><li>Support technical reviews, coordination meetings and project closeout / handover documentation packs.</li><li>Proactively follow up on pending actions, approvals and overdue reviews.</li><li>Develop and maintain document procedures, metadata standards and templates; identify and implement improvements.</li><li>Provide day to day support for document access, retrieval, formatting/numbering and stakeholder queries, while maintaining access controls, data integrity and compliance with internal/ISO/contractual requirements.</li></ul> Requirements: <ul><li>Bachelor’s degree (any discipline) or equivalent.</li><li>2 to 6 years’ relevant document control experience, preferably in construction, engineering, manufacturing, oil &amp; gas or EPC project environments.</li><li>Experience supporting project QMS and contractual/client requirements is preferred.</li><li>Software Proficiency: Strong with MS Office (Word, Excel).</li><li>Experience with document management systems/EDMS such as Microsoft SharePoint, Bentley ProjectWise, DocuWare, or similar document control software. Familiarity with PDF tools and CAD/PDF handling.</li></ul>

Responsibilities: QMS Ownership for Deliverable Software <ul><li>Translate AS9115 Rev A and AS9100:2016 requirements into practical procedures, work instructions, and templates.</li><li>Establish processes covering software planning, development, integration, verification/validation, release, delivery, and post-delivery support.</li><li>Ensure the QMS supports multiple development models (Agile, Waterfall, Incremental) while enforcing required quality controls including reviews, approvals, traceability, and documentation.</li></ul> Software Planning &amp; Requirements Quality <ul><li>Lead the creation and maintenance of Software Quality Plans.</li><li>Establish standards for requirements management ensuring requirements are:</li></ul> <ul><li>Clear</li><li>Unambiguous</li><li>Testable</li><li>Maintain bidirectional traceability from:</li><li>Requirements → Design → Code → Test → Release.</li></ul> Configuration Management &amp; Change Control Define standards for Software Configuration Management (CM) including: <ul><li>Baselines</li><li>Configuration item identification</li><li>Change evaluation and approval</li><li>Configuration status accounting</li><li>Integrate software configuration management with product and system configuration processes.</li><li>Ensure CM covers software, documentation, tools, environments, and build/release artifacts.</li></ul> Supplier &amp; COTS/NDS Management <ul><li>Establish standards for evaluation and acceptance of Commercial Off-The-Shelf (COTS) and Non-Developmental Software (NDS) used in deliverable products.</li><li>Define AS9115 control applicability with both customers and suppliers.</li><li>Support supplier qualification, audits, and incoming verification for software deliverables and services.</li></ul> Verification, Validation &amp; Test Assurance <ul><li>Define verification standards within the QMS including:</li><li>Static analysis</li><li>Peer reviews</li><li>Unit testing</li><li>Integration testing</li><li>System testing</li><li>Regression testing</li><li>Security testing</li><li>Ensure independence of verification activities where required.</li><li>Maintain controlled test environments, data integrity, and objective evidence for compliance audits.</li></ul> Release, Delivery &amp; Post-Delivery Support Develop procedures for: <ul><li>Software release criteria</li><li>Delivery records</li><li>Installation documentation</li><li>Post-delivery issue management</li><li>Patching and configuration updates</li><li>Ensure all processes align with AS9115 standards.</li></ul> Audits, Metrics &amp; Continuous Improvement Lead internal and customer audits related to AS9115/AS9100 compliance. <ul><li>Manage Corrective and Preventive Actions (CAPA).</li><li>Support external and second-party audits with aerospace OEMs.</li><li>Define and track key quality KPIs, including:</li><li>Requirements volatility</li><li>Defect density</li><li>Defect escape rate</li><li>Verification coverage</li><li>Audit findings aging</li><li>Build reproducibility</li><li>Change lead time</li></ul> Requirements: Bachelor’s or Master’s degree in: <ul><li>Software Engineering</li><li>Computer Science</li><li>Systems Engineering or a related discipline.</li><li>Minimum 5 years of experience in software quality or software engineering within aerospace, defense, or other regulated industries.</li><li>Hands-on experience implementing AS9100 quality processes with working knowledge of AS9115 software lifecycle controls.</li></ul> Strong experience in: <ul><li>Requirements management</li><li>Configuration management</li><li>Verification and validation</li><li>Software release governance</li><li>Experience managing COTS/NDS software integration and supplier quality.</li><li>Proven ability to lead audit activities and corrective actions using structured problem-solving tools such as:</li><li>5 Why</li><li>Ishikawa</li><li>8D</li></ul> Preferred Qualifications <ul><li>Experience supporting AS9115 second-party audits with aerospace OEMs.</li><li>Familiarity with DO-178C concepts and coordination with DO-254/ED-80 hardware processes.</li><li>Experience with ALM/PLM and configuration management tools, such as:</li><li>Polarion</li><li>IBM DOORS</li><li>CodeBeamer</li><li>Git / GitLab</li><li>Bitbucket</li><li>Azure DevOps</li><li>Knowledge of CI/CD pipelines, static analysis tools, and unit testing frameworks.</li><li>Exposure to CMMI-DEV processes and experience aligning them with AS9115 quality objectives.</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>Drive quality policy to improve quality awareness, such as QMS training etc.</li><li>Improve quality system implementation&nbsp;</li><li>Prepare for yearly IATF16949 external audit and customer audits&nbsp;</li><li>Organize internal quality system audit. Review and summarize internal audit results to QS supervisor.</li><li>LPA development, internal process audit;&nbsp;</li><li>Follow up and verify the actions for all NC findings</li><li>Well Document Control in the company&nbsp;</li><li>Support management review</li><li>Continual Improvement Action</li></ul> Requirements: Education:&nbsp; <ul><li>Bachelor degree or above in Mechanical, Electronics or relevant&nbsp;</li></ul> Qualification &amp; Certification: <ul><li>IATF 16949 internal auditor;</li><li>APQP, PPAP, FMEA, SPC, MSA certification;</li><li>VDA6.3 internal auditor/authorized auditor</li><li>Experience: More than 5 years of working experience in quality system management, Automotive experience must be.&nbsp;</li></ul> Technical Skill &amp; Competencies: <ul><li>APQP, PPAP, FMEA, SPC, MSA,8D.&nbsp;</li><li>Process audit and product audit skills;</li><li>Familiar with ISO9001, IATF16949;</li><li>Familiar with automotive process and risk management method;</li><li>Proficient in written and oral English;</li><li>Good communication skill, integrity, accountability, logical, self-motivated, ability to work under pressure;</li><li>Good audit and problem-solving skill.</li><li>Understanding the basic HSPM related requirements</li></ul>

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Quality & Reliability Technician

Document Controller

Staff Advanced Quality Engineer (Software)

Associate, Quality Assurance (QMS)

124480 Quality System Engineer

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Quality & Reliability Technician

Document Controller

Staff Advanced Quality Engineer (Software)

Associate, Quality Assurance (QMS)

124480 Quality System Engineer

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