Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Operations Manager

Supervisor – Quality and Reliability Engineer

Senior Site Quality Manager

Manufacturing and Process Development Engineer

Supervisor II Assembly

Manufacturing Engineer

Supervisor III, Production

Document Control Lead

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>

Responsibilities: EH&amp;S (Environment, Health &amp; Safety): <ul><li>Promote a culture of safety across the organization.</li><li>Ensure personnel adhere to established safety guidelines, procedures, and policies.</li><li>Implement lessons learned from security incidents at other facilities to maintain a safe environment.</li></ul> Quality: <ul><li>Promote a culture of quality throughout operations.</li><li>Ensure the operations team follows procedures in their respective areas.</li><li>Support audits from clients and regulatory entities.</li><li>Ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).</li></ul> Production: <ul><li>Foster a respectful, dynamic, and challenging work environment.</li><li>Ensure the fulfillment of internal and external operational goals.</li><li>Uphold ethical and regulatory standards in all team behavior.</li><li>Develop and maintain a 5S culture to support efficient operations.</li></ul> Requirements: Competencies &amp; Skills: Core Competencies: <ul><li>Technical Learning: Demonstrated understanding and experience in intensive manufacturing processes.</li><li>Problem Solving: Subject Matter Expert (SME) in complex problem-solving; able to guide teams through solution analysis.</li><li>Ethics and Values: Uphold company values consistently, rewarding alignment and addressing deviations.</li><li>Action Oriented: Energetic and proactive in addressing operational challenges.</li></ul> Job-Specific Knowledge, Skills, and Abilities: <ul><li>Advanced computer skills (Microsoft Word, Excel, etc.).</li><li>Assertive communication and interpersonal skills.</li><li>Strong planning, organizational, implementation, and monitoring skills to ensure Gantt chart and goal achievement.</li><li>Blueprint interpretation and reading.</li><li>Ability to work effectively under pressure.</li><li>Delegation skills while maintaining accountability for results.</li><li>Customer service orientation.</li><li>Effective time management.</li><li>Knowledge of ISO 9002 and FDA-regulated manufacturing environments.</li><li>Experience promoting continuous improvement projects.</li></ul> Experience &amp; Educational Requirements: Experience: <ul><li>Managerial experience in operations/production.</li><li>Minimum 4 years as a senior supervisor, superintendent, or equivalent role in operations/production.</li><li>Approximately 60% office work and 40% time on manufacturing lines (36 months minimum).</li></ul> Education: <ul><li>Engineering degree or equivalent.</li><li>Master’s degree is desirable.</li></ul> Professional Training &amp; Certifications: <ul><li>Six Sigma Green Belt (preferred).</li></ul>

Responsibilities: <ul><li>Manage the day-to-day activities of the team in a safe environment and be responsible for Health and Safety goals.</li><li>Deliver on all KPIs that help the business achieve its objectives.</li><li>Lead and drive QA initiatives within the functional area.</li><li>Provide quality input and support to Manufacturing, Engineering, Prototype, and Commercial functions.</li><li>Lead, coordinate, and maintain risk assessment documentation (e.g., FMEAs).</li><li>Investigate the root cause of quality issues and implement timely and effective corrective actions to prevent recurrence for both customer and internal issues.</li><li>Strategically lead new product introduction (NPI) and contract reviews from a QA perspective.</li><li>Prepare and update Operations procedures and associated documentation.</li><li>Overall responsibility for functional area GMP standards and compliance, including promoting quality awareness.</li><li>Establish inspection standards, sampling plans, and test methods.</li><li>Report quality metrics to management.</li><li>Develop strong links with customer organizations and other project stakeholders.</li><li>Review validation documentation for the functional area.</li><li>Perform and support internal and external audits to ISO and FDA requirements.</li><li>Actively contribute to the continuous improvement of the Quality Management System.</li><li>Supervise and provide direction to quality personnel.</li><li>Perform other tasks as directed by the Operations Quality Manager in line with company goals.</li></ul> Requirements: <ul><li>Level 8 degree in Science, Engineering, or related field.</li><li>Minimum of 5 years industry experience in a medical device manufacturing environment.</li><li>People management experience.</li></ul> Key Requirements <ul><li>Clear understanding of medical device quality systems and requirements, including measurement techniques.</li><li>Experience managing and leading a team.</li><li>Strong CAPA experience.</li><li>Strong root cause analysis and problem-solving skills.</li><li>Knowledge of FDA and ISO Quality systems for medical device companies is desirable.</li><li>Experience in new product introduction (NPI) and manufacturing process transfers is desirable.</li><li>Demonstrated excellent organizational skills and ability to work independently.</li><li>Excellent written and verbal communication skills.</li></ul>

Responsibilities: <ul><li>Lead and develop the quality team, fostering a culture of continuous improvement and cross-department collaboration.</li><li>Partner with manufacturing, engineering, and global quality teams to ensure product quality, process capability, and regulatory compliance.</li><li>Champion and uphold plant-wide quality standards, policies, and systems in alignment with corporate and customer requirements.</li><li>Monitor and report key quality performance indicators (e.g., customer complaints, internal defects) and provide actionable insights to plant leadership.</li><li>Manage internal and external audits and ensure audit readiness across the facility.</li><li>Oversee plant-wide quality improvement initiatives to reduce defects and scrap and improve process control and product reliability.</li><li>Lead root cause analysis, corrective actions, and continuous improvement efforts to address recurring quality issues.</li><li>Collaborate with engineering and production teams to ensure new product introduction (NPI) meets quality standards.</li><li>Mentor and coach quality team members to foster a high-performance culture.</li><li>Travel as required to support internal and external customer needs and NPI programs.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering, Quality, or a related technical field (preferred).</li><li>8+ years of progressive quality experience in a manufacturing environment.</li><li>Strong knowledge of ISO 9001 and regulatory compliance standards.</li><li>Minimum of 3 years in a leadership role managing quality teams.</li><li>Expertise in Lean Manufacturing and advanced quality methodologies.</li><li>Proven experience with 8D problem solving, FMEA, DOE, SPC, and safe launch processes.</li><li>Proficiency in quality data analysis tools such as Minitab, JMP, or similar.</li><li>Excellent communication, analytical, and leadership skills, with the ability to inspire and motivate teams.</li></ul>

Responsibilities: <ul><li>Extrusion Process Including Equipment/Tooling Development for NPI: Develop Bulk Cable advanced process technology in order to effectively support production and new cable business development.</li><li>Sample Making Program Monitor: Monitor sample making program and solve technical issues in order to effectively support production and new cable business development.</li><li>Process documents create and maintain: Create SOP/VP based on product drawing and process need, to support bulk cable NPI</li><li>Creation of Process Documentation &amp; Work Instructions acc. to ISO-9001 standards</li><li>Coordinate and lead the introduction of Engineering changes and new products.</li><li>Implement TEOA specific KPI and Reporting standards.</li><li>Monitor OEE, Scrap rate and Line efficiency and lead action plans to enhance these metrics.</li></ul> Requirements: <ul><li>Associate degree with engineering background.</li><li>Min.5 years high speed Bulk Cable manufacturing working experience.</li><li>Know well extrusion process.</li><li>Ability to solve critical issues and make process more stable with effective tools like FACA,DOE and SPC etc.</li><li>Good logical analysis skills, know well SI.</li><li>Good communication skill, integrity, accountability.</li><li>Good evaluation process capability skills, know well BOP,P-FMEA,DFM.</li><li>Basic data analysis skills, know well CPK,PPK,Yield analysis, T-test,Tolerance,Correlation,Regression.</li><li>Basic reading and writing English.</li></ul>

Responsibilities: <ul><li>To Plan and establish production work schedule to meet delivery times and best utilize company production capacity by releasing work orders.</li><li>Scheduling for materials and production in Coordination with staff throughout the company to ensure timely delivery to customers by obtaining agreement for product ship dates.</li><li>To take full responsibility of the shift in terms of management of staff, management of production and quality targets and to ensure the smooth running of the production processes, produced within the shift in line with the company’s quality systems, processes and procedures.</li><li>To demonstrate excellent people management skills to develop and motivate direct reporting staff and to ensure that Health and Safety rules and regulations are adhered during the shift in line with the companies Health and Safety policy.</li><li>Confer with other supervisors and managers to coordinate operations and activities within or between departments.</li><li>Monitor, measure, and report on production related process performance/KPI’s, general issues and ensure the team is self-managed (SMT) on problem solving and troubling shooting skills to identify root causes and take fast effective action to resolve the problems in hand.</li><li>Assist in maintaining stock rooms and inventory accuracy and participate in physical inventory counts.</li><li>Demonstrate customer centric approach and adherence to customer expectations to promote a positive company image.</li><li>Responsible for on-the-job training of directs. Play active role in the TEOA plan/Kaizen initiative to achieve plans for future growth within the company.</li><li>Set departmental process and link to ISO procedure.</li><li>Stake holder Management</li></ul> Requirements:&nbsp; Professional Experience <ul><li>5 to 7 Years of experience in the same field and industry.</li><li>Bachelor’s degree in mechanical or Electronics Engineering</li><li>Advanced skills with Microsoft Office, especially Excel</li></ul>&nbsp;Leadership Experience: <ul><li>Deep understanding and professional experience of people management.</li><li>Excellent communication and convincing skills</li><li>Self-driven and detail-oriented</li><li>Desire to solve problems with analytical thinking</li><li>Good at people management and execution skills</li><li>Strong organizational skills and a team player</li></ul>&nbsp;Project Experience: <ul><li>Expert in material and production planning.</li><li>Knowledge of SAP</li><li>Quality and Environmental Management System knowledge</li><li>Excellent people management skills to develop and motivate direct reporting staff and to ensure that Health and Safety rules and regulations are adhered to during the shift in line with the companys Health and Safety policy</li><li>Assist in maintaining stock rooms and inventory accuracy and participate in physical inventory counts.</li><li>Play an active role in the TEOA plan/Kaizen initiative to achieve plans for future growth within the company.</li></ul>&nbsp;Qualifications: <ul><li>Bachelor of Science or above degree and an engineering background.</li><li>Preferably Mechanical, Electrical/Electronics, and Industrial Engineer</li></ul>&nbsp;Other Requirements: <ul><li>3-5+ years’ experience as a practitioner as an Engineer.</li><li>Knowledge in Mechanical, Electrical, and Pneumatic drawings.</li><li>Solid understanding of health and safety regulations and practices.</li><li>Strong decision-making and problem-solving skills.</li><li>Excellent communication and interpersonal skills.</li><li>Computer literate with capability in email, MS Office, and related communication tools.</li><li>Knowledge in various machines from Stamping, Molding, Plating, and Assembly.</li></ul>

Responsibilities: <ul><li>Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.</li><li>Provide technical support for new product introduction (NPI), including process design, tooling, and equipment validation.</li><li>Conduct root cause analysis and lead corrective/preventive actions (CAPA) to&nbsp;</li><li>resolve production issues.</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Supply Chain, Maintenance) to ensure smooth project execution and production readiness.</li><li>Prepare and maintain process documentation, work instructions, and training materials.</li><li>Monitor key production metrics (yield, scrap, cycle time, downtime) and implement continuous improvement initiatives.</li><li>Participate in lean manufacturing, Six Sigma, and Kaizen activities to drive operational excellence.</li><li>Ensure compliance with safety standards, environmental regulations, and ISO/IATF quality system requirements.</li><li>Support cost reduction projects through process improvement, automation, and supplier collaboration.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.</li><li>3–5 years of relevant experience in manufacturing engineering; automotive or electronics industry experience preferred.</li><li>Strong knowledge of manufacturing processes such as machining, assembly, injection molding, stamping, or PCB assembly (depending on industry).</li><li>Familiarity with APQP, PPAP, FMEA, Control Plan, and other quality tools.</li><li>Proficiency in CAD software (e.g., AutoCAD, SolidWorks, Creo) and MS Office.</li><li>Hands-on experience with Lean Manufacturing and problem-solving methodologies (5Why, 8D, DMAIC).</li><li>Good communication and coordination skills; able to work in cross-functional and multicultural teams.</li><li>English: able to read and write technical documents; spoken English is a plus.</li></ul>

Responsibilities: <ul><li>Supervise and lead production team members across assigned shifts and production lines.</li><li>Ensure daily production schedules are met in compliance with safety, quality, and delivery requirements.</li><li>Monitor key performance indicators (OEE, yield, scrap, downtime) and implement corrective actions as needed.</li><li>Drive continuous improvement initiatives in productivity, cost reduction, and process efficiency.</li><li>Partner with Manufacturing Engineering, Quality, and Maintenance teams to resolve process and equipment issues.</li><li>Provide training, coaching, and performance feedback to team members to build skill and capability.</li><li>Enforce compliance with EHS standards, company policies, and 5S/lean manufacturing practices.</li><li>Ensure proper manpower planning, shift scheduling, and attendance management.</li><li>Manage production documentation, reporting, and escalation of issues to management.</li><li>Support new product introduction (NPI) and ensure smooth handover to mass production.</li></ul> Requirements:﻿ <ul><li>Bachelor’s degree/diploma in Manufacturing, Mechanical, Industrial Engineering, or related field.</li><li>Minimum 5–7 years of production experience in high-volume manufacturing, with at least 3+ years in a supervisory/lead role.</li><li>Strong knowledge of lean manufacturing principles, problem-solving, and root cause analysis.</li><li>Good understanding of ISO/IATF 16949, EHS, and quality management systems.</li><li>Proven leadership, people management, and conflict resolution skills.</li><li>Ability to work in a fast-paced, 24/7 manufacturing environment with flexibility to support multiple shifts.</li></ul>

Role Description: <ul><li>The Document Control Lead will serve as a key quality function responsible for establishing, maintaining, and managing the document control systems critical to ensuring regulatory compliance, data integrity, and operational readiness for a greenfield sterile injectable IV bag manufacturing facility.</li><li>This role will drive the creation, organization, distribution, and maintenance of all controlled documentation required to support GMP operations, regulatory submissions, and inspection readiness.</li><li>The incumbent will play a vital role in building document management systems during site startup and ensure robust control throughout the facility lifecycle.</li><li>This role will also be the site technical resource for coordination and qualification of corporate quality electronic document systems including Trackwise, Learning Management System, and the Document Control System.</li></ul> Responsibilities: <ul><li>Develop and implement comprehensive document control systems aligned with FDA cGMP, ICH, ISO, and company quality standards.</li><li>Manage the creation, review, approval, issuance, and archival of controlled documents including SOPs, batch records, forms, protocols, and reports.</li><li>Establish electronic document management systems (EDMS) and ensure proper system validation and security controls are in place.</li><li>Lead training initiatives for site personnel on document control processes, document authoring standards, and compliance requirements.</li><li>Coordinate cross-functional document reviews, version control, change management, and timely issuance of current documents to ensure operational readiness.</li><li>Monitor and ensure compliance with controlled document workflows, ensuring timely processing and adherence to procedural timelines.</li><li>Support regulatory inspections, internal audits, and external audits by providing controlled document access, retrieval, and documentation support.</li><li>Maintain accurate and organized archives (both physical and electronic) to ensure data integrity, traceability, and inspection readiness.</li><li>Collaborate with Quality Assurance, Validation, Operations, Engineering, and Regulatory Affairs to ensure alignment of document control processes.</li><li>Continuously improve document control processes, leveraging automation, best practices, and compliance trends to ensure long-term system robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in Life Sciences, Quality Management, or related field.</li><li>5+ years of experience in GMP-regulated pharmaceutical document control, preferably in sterile manufacturing.</li><li>Prior experience implementing or managing electronic document management systems (EDMS) strongly preferred.</li><li>Strong understanding of FDA cGMP, ICH, ISO 9001, and data integrity principles.</li><li>Experience supporting regulatory inspections and audits.</li></ul> Skills/Competencies: <ul><li>Expertise in controlled document management principles and electronic systems.</li><li>Strong attention to detail, accuracy, and compliance.</li><li>Excellent organizational and time management skills.</li><li>Ability to manage multiple priorities and document workflows simultaneously.</li><li>Strong cross-functional collaboration and communication skills.</li><li>Proficiency in EDMS platforms, document lifecycle management, and version control.</li><li>Ability to work in a greenfield/startup environment and build systems from the ground up.</li></ul>

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18 iso Jobs found

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Operations Manager

Supervisor – Quality and Reliability Engineer

Senior Site Quality Manager

Manufacturing and Process Development Engineer

Supervisor II Assembly

Manufacturing Engineer

Supervisor III, Production

Document Control Lead

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18 iso Jobs found

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Operations Manager

Supervisor – Quality and Reliability Engineer

Senior Site Quality Manager

Manufacturing and Process Development Engineer

Supervisor II Assembly

Manufacturing Engineer

Supervisor III, Production

Document Control Lead

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TALENT

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