Senior Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Senior Site Quality Manager

Supervisor II Assembly

Manufacturing Engineer

Supervisor III, Production

Document Control Lead

Manufacturing & Process Development Engineer II (Wire & Cable)

Data Engineer

Supplier 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: <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>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>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>

Responsibilities:&nbsp; <ul><li>Lead process development, implementation, and documentation for bulk cable manufacturing.</li><li>Support product/process validation and transfer activities.</li><li>Assist with product qualification, working closely with engineering and test lab teams.</li><li>Partner with Product Development/Design Engineering to ensure manufacturability.</li><li>Interact with test laboratories on process/product qualification tasks, including DOE, PFMEA, 8D investigations, and Failure Analysis (FA).</li><li>Support tooling specification and design for manufacturing processes.</li><li>Provide engineering support to additional manufacturing sites as required.</li><li>Collaborate with suppliers to ensure process compliance and capability.</li><li>Support SAFE (Safety Activities For Employees) and ISO quality compliance initiatives.</li><li>Provide technical support for manufacturing maintenance activities.</li><li>Participate in cross-functional projects that support business growth and continuous improvement.</li></ul> Requirements:&nbsp; <ul><li>Strong knowledge of materials, processes, and systems used in wire and cable manufacturing.</li><li>Proficient in CAD software for tooling and process design.</li><li>Practical knowledge and experience with SPC (Statistical Process Control), Six Sigma, and Lean Manufacturing principles.</li><li>Ability to manage multiple projects and deliver results under tight timelines.</li><li>Willingness to travel internationally up to 30% as required.</li></ul>

Responsibilities: <ul><li>Design and development experience in Go, Python and docker.</li><li>Collaborate closely with product management to ensure the platform provides a seamless user experience.</li><li>Engage in code and design reviews, championing quality and best practices.</li><li>Continuously innovate, integrating new technologies and methodologies into your work.</li><li>Collaborate with cross-functional teams to integrate new features and expand the platforms capabilities.</li><li>Provide deep technical customer support when necessary, troubleshooting complex issues and ensuring user satisfaction.</li><li>Actively participate in bug fixing and maintaining the platform, ensuring smooth and uninterrupted service to users.</li></ul> ﻿Requirements: <ul><li>Familiarity with ISO 27001, GDPR and OWASP guidelines.</li><li>Strong understanding of networking hardware, protocols and security.&nbsp;</li><li>7 to 8 Years of experience.</li></ul>

Responsibilities: <ul><li>Quality Key Contact and Account owner for assigned suppliers.</li><li>Owner of supplier quality performance for assigned suppliers and commodity.</li><li>Organize and Perform Suppliers Scorecard Reviews, Business Reviews, Complaint reviews and other management reviews.</li><li>Quality representative on Sourcing decisions</li><li>Participate / Leads Audits at suppliers (Systematic, process, etc.) per the Annual Audit Plan or Problem-Solving activities. Performs new supplier qualification audit when SDE function is not available in the region.</li><li>Owner of supplier 8D (D4~D8) and 8D quality rating.</li><li>Supports IQE on Complaint Handling for the assigned suppliers (as Escalation step for IQE)</li><li>Define and track Performance Agreements.</li><li>Supplier improvement – Participate in 6-Sigma lean projects, Kaizen events, Quality Improvement Plan activities (CoPQ, CCR, SATI etc.).</li><li>Supplier Training – Provide Technical aid and Training to suppliers when necessary to achieve the required Quality level in collaboration with SDE if needed.</li><li>Contributes to Lessons Learned documents in collaboration with other supplier quality.</li></ul> Requirements: <ul><li>At least 5 years of experience within connector and cable assembly Quality</li><li>Expert Knowledge on ISO9001. Preferred on IATF16949, ISO 14000 and other industry standards</li><li>Certified ISO 9001 auditor by the 2nd party auditor</li><li>Demonstrated skills in a matrix environment</li><li>Working Knowledge on specific product and process as needed (e.g., Molding, Stamping, PCB/PCBA, diecasting, bulk cable …)</li><li>Be familiar with the tools related to supplier APQP process, include but not limit to APQP, PPAP, FMEA, CP, MSA, SPC, R@R and 8D.</li><li>Ability to work across cultures and countries effectively.</li><li>Thorough knowledge of Problem-Solving tools</li><li>Process Auditor Skills mandatory</li><li>SAP basic knowledge</li><li>Knowledge in GD&amp;T and Advance knowledge reading technical drawings and specifications</li><li>Presentation skills</li><li>Communication and negotiation skills</li><li>Coaching skills</li></ul>

Skills

Industry

Location

Jobtitle

12 iso Jobs found

Senior Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Senior Site Quality Manager

Supervisor II Assembly

Manufacturing Engineer

Supervisor III, Production

Document Control Lead

Manufacturing & Process Development Engineer II (Wire & Cable)

Data Engineer

Supplier Quality Engineer

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

12 iso Jobs found

Senior Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Senior Site Quality Manager

Supervisor II Assembly

Manufacturing Engineer

Supervisor III, Production

Document Control Lead

Manufacturing & Process Development Engineer II (Wire & Cable)

Data Engineer

Supplier Quality Engineer

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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