Senior Quality & Reliability Engineer

Senior Project Management Engineer

Manufacturing Manager / Staff Engineer - Cable Assembly

Manufacturing Manager / Staff Engineer - Cable Making

QC Lab Sample Coordinator

QE Specialist

Supply Chain Business Process Expert

Operations Manager

Executive Assistant to Group CEO (Operations – Steel & Power)

Quality Engineer

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: 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: Planning and Budgeting: <ul><li>Develop and implement section budget and plan, and monitor the achievement of the budget in order to achieve targeted department performance.</li></ul> Policies and Procedures: <ul><li>Implement new global product development policies, procedures and systems; and maintain and develop local product development policies, procedures in order to meet company global requirements.</li></ul> People Management and Development: <ul><li>Allocate and balance the allocation of work across direct reports; review and provide timely performance feedback to direct reports; mentor, develop and motivate them; help resolve people/functional issues in the team in order to achieve targeted performance and retain key talent.</li></ul> Manufacturing Engineering: <ul><li>Develop advanced process technology; review automation project, tebit saving project; review new sample making reports; and provide technical support to key project in order to effectively support production and business development.</li></ul> Asset Management: <ul><li>Manage fixed asset and find new opportunity to reuse idle asset on new project in order to reduce product cost.</li></ul> Requirements: <ul><li>Bachelor degree with engineering and sciences</li><li>8-10 years cable assembly working experience including 4 years management experience.</li></ul>

Responsibilities: Planning and Budgeting: <ul><li>Develop and implement section budget and plan, and monitor the achievement of the budget in order to achieve targeted department performance.</li><li>Policies and Procedures</li><li>Implement new global product development policies, procedures and systems, and maintain and develop local product development policies, procedures in order to meet company global requirements.</li></ul> People Management and Development: <ul><li>Allocate and balance the allocation of work across direct reports, review and provide timely performance feedback to direct reports, mentor, develop and motivate them, help resolve people/functional issues in the team in order to achieve targeted performance and retain key talent.</li></ul> Product Design Engineering (Cable Making): <ul><li>Review product data reports(including drawings, BOM, routine, costs), review and approve new product design engineering programme and ECN(Engineering Change Notice) control in the system in order to support new business development.</li><li>Lead new product and new technology development program in order to meet the potential market demand.</li></ul> Project Management (Cable Making): <ul><li>Approve cable making new project proposal and allocate project/resources to PM, review projects progress and provide cross function coordination, attend design review meeting, and review and approve the release of final design in order to ensure successful project implementation."</li></ul> Cable Making Manufacturing Engineering:	 <ul><li>Develop cable making advanced process technology, review cable making machine design, supervise of new product pilot run including SOP (Standard Operation Process),</li><li>review new sample making reports, and provide technical support to key process problem solving in order to effectively support production and new cable business development</li></ul> Requirements: <ul><li>Bachelor degree with engineering and sciences</li><li>8 years cable making working experience including 4 years management experience.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC sample reconciliation and disposal.</li><li>Tracks inventory of product samples, stability samples, and test materials in the lab.</li><li>Uses laboratory software for sample, reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with samples.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Send samples for outside testing. Submit samples to the appropriate labs for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the submission of samples.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting sample processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations&nbsp; <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any sample and reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance&nbsp; <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computer savvy.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Role Description: <ul><li>As a member of our ISC Global Automotive team, you will focus on enhancing our S&amp;OE process and driving the successful implementation of SAP APO PP/DS or S4 ePPDS as well as SAP IBP in our manufacturing plants.</li><li>Leveraging your extensive experience with advanced planning software, you will help define business requirements, ensure system readiness, and guide local teams through adoption and optimization processes.</li></ul> Responsibilities: <ul><li>Drive initiatives in automation and advanced planning systems to enhance and refine S&amp;OE processes.</li><li>Lead cross-functional teams - including project managers, subject matter experts, and IT partners - in defining business requirements, designing.</li><li>Provide project updates to various stakeholders at different levels of the organization.</li><li>Focus on timely project completion, resource deployment, staying within budget and appropriate adoption by end users.</li><li>Develop comprehensive training materials for end users and deliver training sessions and champion best practices and contribute to the development of standardized processes</li></ul> Requirements: <ul><li>Master’s degree or equivalent in Supply Chain, Materials Management, Business, Logistics, Engineering, or related field.</li><li>5 years’ hands-on experience in supply chain and operations, ideally manufacturing planning.&nbsp;</li><li>Extensive user-side experience in SAP APO PP/DS or S4 ePPDS implementation (essential); experience with SAP IBP Response is highly desirable.</li><li>Proven ability to use and train others on APO PP/DS and/or S4 ePPDS tools.</li></ul>

Responsibilities: Policies and Procedures (10%): <ul><li>Develop and implement the manufacturing related policies and procedures in order to align with government regulation and corporate policy, organize the formulation of the responsibilities of management personnel at all levels, and optimize the internal structure and staffing.</li><li>Develop and implement assembly function budget and plan allocate function target to subordinates and monitor the achievement of the budget and overall performance in order to achieve targeted of Plant performance.&nbsp;</li></ul> People Management (15%): <ul><li>Allocate and balance work across direct reports&nbsp;&nbsp;</li><li>Review and provide timely performance feedback to direct reports&nbsp;&nbsp;</li><li>Mentor, develop and motivate them&nbsp;</li><li>Help resolve people/functional issues in the team&nbsp;</li><li>Submit manpower application and interview the candidates in order to achieve targeted department performance and retain key talent.&nbsp;</li></ul> Production (25%): <ul><li>Supervise and monitor the production activities and process&nbsp;</li><li>Help to solve critical production issues&nbsp;</li><li>Cooperate with other functions within molding department and other departments in getting necessary support in order to ensure the normal day-to-day production.&nbsp;</li></ul> Assembly (25%):&nbsp; <ul><li>Review the maintenance plan&nbsp;</li><li>Monitor the maintenance plan execution&nbsp;</li><li>Approve the Purchase Request for spare parts&nbsp;</li><li>Provide overall mold/Die/Tool maintenance instruction and monitor the execution in order to ensure the normal operation of die and improve daily operating efficiency.&nbsp;</li></ul> Equipment maintenance (5%): <ul><li>Review the maintenance plan&nbsp;</li><li>Monitor the maintenance plan execution&nbsp;</li><li>Approve the Purchase Request for equipment and parts&nbsp;</li><li>Provide overall equipment maintenance instruction and monitor the execution in order to ensure equipment operate reliably and improve daily operating efficiency.&nbsp;</li></ul> Engineering (10%):&nbsp; <ul><li>Allocate new projects to engineers&nbsp;</li><li>Monitor the new project process and control the cost and schedule&nbsp;</li><li>Provide cross functions/departments coordination&nbsp;</li><li>Help to solve critical technical issues in order to ensure the successful completion of the project.&nbsp;</li></ul> EHS (5%):&nbsp; <ul><li>Formulate and perfect the department EHS management system and operational procedures, and ensure the effective implementation.&nbsp;</li><li>Fully understand and implement EHS responsibilities to ensure EHS work in department meets relevant requirements&nbsp;</li><li>Set departmental and individual EHS performance targets according to laws and regulations and requirements of the company, and check and evaluate the completion of the targets regularly&nbsp;</li><li>Check the safety situation of production site regularly to eliminate all kinds of unsafe factors and prevent accidents.&nbsp;</li></ul> Project Management and Activity (10%):&nbsp; <ul><li>To reduce the costs and improve efficiency of the department, organize and plan key improvement projects, and monitor the implementation of these projects (Tebit Saving, Kaizen)&nbsp;</li><li>In order to improve and cooperate with the plant in implementing the excellent operation objectives, actively participate in training and use tools for improvement, such as VS Transformation, CCF, etc.</li></ul> Requirements: <ul><li>Bachelor and above Degree&nbsp;</li><li>Good English skills (written and oral)&nbsp;</li><li>Min. 10 years shopfloor management experiences in elec. Industry, above two years on managerial positions&nbsp;</li><li>Solid Lean/6 Sigma knowledge and project experiences&nbsp;</li><li>Familiar with quality system and tools&nbsp;</li><li>Rich experiences in operator training and development&nbsp;</li><li>Planning knowledge and experiences&nbsp;</li><li>Proficient PC skills.</li></ul>

Responsibilities: <ul><li>Assist the CEO in reviewing plant performance, production data, and technical reports from steel and power units.</li><li>Coordinate with project, maintenance, and operation teams for updates on production, energy consumption, and process optimization.</li><li>Serve as the liaison between the CEO’s office and functional heads, ensuring timely follow-up and closure of key action items.</li><li>Organize and document strategic meetings, board reviews, and inter-departmental coordination discussions.</li><li>Draft high-quality communications, reports, and briefing materials for the CEO.</li><li>Analyse operational KPIs and provide insights or recommendations for productivity and efficiency improvements.</li><li>Track progress of ongoing expansion, modernization, or efficiency projects.</li><li>Manage CEO’s schedule, travel plans, and meeting coordination where required.</li><li>Ensure confidentiality and proper handling of sensitive business information.</li><li>Support in preparation for stakeholder meetings (investors, government, JV partners, etc.).</li></ul> Requirements: <ul><li>B.E./B.Tech in Mechanical / Metallurgy / Electrical / Industrial Engineering, MBA or PGDM in Operations / Strategy (preferred from top ranked institutes)</li><li>Minimum 5–10 years of experience in plant operations, project management, or technical coordination roles in the steel/power sector.</li><li>Strong analytical, communication, and presentation skills.</li><li>High proficiency in MS Office (Excel, PowerPoint, Project) and ERP systems.</li></ul>

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>

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193 control systems Jobs found

Senior Quality & Reliability Engineer

Senior Project Management Engineer

Manufacturing Manager / Staff Engineer - Cable Assembly

Manufacturing Manager / Staff Engineer - Cable Making

QC Lab Sample Coordinator

QE Specialist

Supply Chain Business Process Expert

Operations Manager

Executive Assistant to Group CEO (Operations – Steel & Power)

Quality Engineer

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Skills

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193 control systems Jobs found

Senior Quality & Reliability Engineer

Senior Project Management Engineer

Manufacturing Manager / Staff Engineer - Cable Assembly

Manufacturing Manager / Staff Engineer - Cable Making

QC Lab Sample Coordinator

QE Specialist

Supply Chain Business Process Expert

Operations Manager

Executive Assistant to Group CEO (Operations – Steel & Power)

Quality Engineer

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

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COMPANY

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