GPS (Global Product Support) Engineer

Staff Advanced Quality Engineer (Software)

Production Technician I

Customer Quality Engineer (CQE)

Responsibilities: <ul><li>Develop new procedures and Best Known Methods (BKMs) to service new products. Contribute to the FMECA process.&nbsp;&nbsp;</li><li>Participate in or own first chamber Build &amp; Test in Apps lab. Solve issues, or work with Engineering to address issues identified.&nbsp;</li><li>Work with Manufacturing to develop procedures and participate (if required) on New Product final test</li><li>Partner with Quality &amp; Reliability (Q&amp;R) group to review and address Top Field Issues. Participate in or own CAPA process. Conduct or facilitate Failure Analysis (FA) if needed</li><li>Develop and document procedures to install (start-up), retrofit and maintain the product (Technical Product Manuals)</li><li>Develop new procedures, Customer Engineering Notices (CENs), Internal Service Bulletins (ISBs) and troubleshooting guides as required</li><li>Collect process and qualification data to create product Best Known Methods (BKMs)</li><li>Develop initial training package for new products and work with Global Technical Training (GTT) to develop training class. Train Customer Engineers (CEs), Process Engineers (PSEs) and Technical Product Support (TPS) assigned to customers who will receive ELS Shipments, prior to shipping</li><li>Identify new parts that require to be stocked by AGS and work with them to ensure parts are stocked in correct locations</li></ul> Requirements: <ul><li>More than 5 years of relevant equipment experiences in the semiconductor industry</li><li>Strong understanding of Vacuum chambers used in PVD or CVD, wet cleans products as well as hands-on skills in Electro mechanical semiconductor assemblies</li><li>Excellent communication and interpersonal skills</li><li>Confident in liaising with internal and external stakeholders of various seniorities</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>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

Responsibilities:﻿ <ul><li>Serve as the main contact for customer complaints and quality issues—coordinate root cause analysis and corrective actions (8D, CAPA), ensuring robust and timely responses.</li><li>Monitor complaint trends, DPPM, COPQ, warranty returns, and initiate improvement initiatives when necessary</li><li>Investigate internal and supplier quality issues; lead supplier audits, performance evaluations, process audits, and enforce corrective measures</li><li>Review customer contracts and quality requirements (PPM targets, FAI demands, Q-certifications); communicate deviations and ensure alignment across internal teams.&nbsp;</li><li>Conduct onsite visits to customer plants and supplier locations for quality discussions, complaint containment, and relationship building</li></ul> Requirements: <ul><li>Must have experience in the automotive industry (Tier 1 or Tier 2).</li><li>Familiarity with quality management for connectors, harnesses, and cable products is preferred (but not mandatory).</li><li>Approximately 5 years, ideally under 30 years of age, with growth potential.</li><li>Familiarity with customer quality complaint handling processes.</li><li>Proficiency in quality tools (e.g., 8D, 5 Whys, FMEA).</li><li>Preference will be given to candidates with AQE/PQE experience.</li><li>Working proficiency in English is a plus.</li><li>Associate degree or higher; a bachelors degree is preferred.</li></ul>

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4 capa Jobs found

GPS (Global Product Support) Engineer

Staff Advanced Quality Engineer (Software)

Production Technician I

Customer Quality Engineer (CQE)

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GPS (Global Product Support) Engineer

Staff Advanced Quality Engineer (Software)

Production Technician I

Customer Quality Engineer (CQE)

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

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