Senior Quality & Reliability Engineer

Finance Business Partner

QE Specialist

Supv III Customer Service

HR Business Partner IV

Operations Manager

Assembly Supervisor

Quality Engineer

Strategic Sourcing Analyst

Associate, Quality Assurance (QMS)

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>The Finance Business Partner, Operations will be providing timely, relevant and accurate information and insightful analysis to facilitate decision-making of senior management.</li><li>Developing the capability to drive swift data extraction and visualization bringing visibility and transparency of key business metrics.</li><li>Focused on finding meaningful insights to support continued and sustainable profitable growth of the our client business.</li><li>Drive improvement in the conversion cost and site fixed overhead vs budget and historical periods.</li><li>Also, bringing actionable insights, identity focus areas and run simulations for site management to optimize the cost level, in line with forecasted business activity.</li><li>Need monthly tracking and action monitoring, working collaboratively with site teams across different functions, and create visibility with global manufacturing team on the improvement actions.</li><li>Drive digital transformation journey of finance function and be instrumental in increasing utilization of BI tools, especially Power BI.</li><li>To include developing the dashboards and power query models required to achieve efficiency in data extraction and visualization.</li><li>Understand diverse internal and external data source and its architecture.</li><li>Able to integrate various data source for seamless automation of business analysis resulting in optimization of core financial workflows, enhancing efficiencies.</li><li>Able to perform analysis using large complex dataset, enhance the reports to improve performance tracking against targets and trend identification.</li><li>Effective contribution in annual budgeting and monthly forecasting process, such as developing templates for end-to-end budget planning and forecasting process.</li><li>Build and foster strong cross-functional relationships across business constituencies and stakeholders specially group support functions like Supply Chain, Manufacturing Ops and Procurement. Help the company understand how the pieces fit together to drive performance and strengthen the team’s partnership and influencing skills in pursuit of growth.</li><li>Price, Mix and Volume Analysis for Margin Improvements</li><li>Proactive participation in various business improvement/ad hoc projects.</li><li>Manages the overall Financial Reporting and Analysis activities in the production and delivery of all standard reporting (including template and chart updates), ad hoc reporting, presentation materials; and non-pricing / profitability (costing) analysis for the business, in accordance with defined standards.</li></ul> Requirements: <ul><li>At least 8-10 years’ work experience in Finance with at least 6 years’ experience in FP&amp;A</li><li>Experience working in manufacturing environment is a must</li><li>Strong business acumen.</li><li>Strong financial, technical, and quantitative analytical skills</li><li>In-depth knowledge of accounting principles, practices and regulatory issues and their application to a wide variety of areas</li><li>Ability to take ownership of a task or process, and see it through from inception to completion</li></ul> Preferred Skills <ul><li>Proven track record of developing and implementing value-added financial analysis</li><li>Self-awareness and ability to handle tight deadlines and manage complex business challenges</li><li>Demonstrated experience in analyzing and synthesizing complex financial data into meaningful executive summary statements</li><li>Excellent verbal and written skills, analytical thinker / problem solver, interpersonal skills, attention to details</li><li>Advance Excel skill, MS office and data management, Power BI skill is added advantage</li></ul> Key Relationships with Internal and External Stakeholders <ul><li>Operational Leadership</li><li>Site Finance Controllers</li><li>Group Finance Team</li><li>Site GMs and Operation team</li></ul> Additional Notes <ul><li>Sound financial knowledge with Chartered Accountant background</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 Manager in Solution Center, you will be at the forefront of driving transformational strategies focused on creating exceptional customer experiences.</li><li>Your leadership will be pivotal in establishing our brand as the preferred supplier by fostering strong customer relationships and steering your team towards unparalleled service excellence and growth.</li></ul> Responsibilities: <ul><li>Lead with Accountability: Spearhead your team to achieve specific departmental goals, focusing on delivering a superior Customer Experience.</li><li>Cultivate Customer Relationships: Empower your team to enhance and expand customer engagement.</li><li>Talent Acquisition and Development: Recruit and nurture top talent, building a team that embodies our vision and drives organizational transformation.</li><li>Champion of Change: Lead by example in adopting transformation initiatives and fostering a culture of positive change.</li><li>Operational Excellence: Instill a mindset of continuous improvement, enhancing team efficiency and service quality.</li><li>Career Development: Offer opportunities for team growth and development, preparing them for future career advancements.</li><li>Cross-Functional Collaboration: Work seamlessly with internal partners in different BU’s, engineering, planning, and sales to ensure comprehensive customer support.</li></ul> Requirements: <ul><li>Experience in a shared service environment.</li><li>Stake Holder management experience</li><li>Track record of successful change management in Customer Care.</li><li>Leadership experience in large, multi-layered teams.</li><li>8 + years in multinational Customer Care operations, with at least 5 years in a relevant role.</li><li>Effective collaboration across all organizational levels.</li><li>Industry-specific experience is advantageous.</li><li>Exceptional communication skills.</li></ul>

Overview: <ul><li>The ICT business unit HRBP – Plant serves as a strategic business partner and trusted thought partner to Plant Leaders and in country senior Management.</li><li>This position is located on-site, but a hybrid work schedule will also be considered Serve as the HR site leader for the Tullahoma facility, acting as a trusted advisor to site leadership and aligning HR support with key business initiatives.</li></ul> Responsibilities: <ul><li>Partner with the broader HR network to deliver strategic talent solutions, organizational design, and effectiveness initiatives, fostering a One HR mindset.</li><li>Provide guidance on leadership development, succession planning, and talent pipeline strategies to support long term organizational growth.</li><li>Champion diversity, engagement, and inclusion efforts, with a global mindset and focus on creating equitable access to development and information.</li><li>Coach and support managers on performance, team effectiveness, and employee development to enhance leadership capability and culture.</li><li>Lead and resolve complex employee relations matters, ensuring legal compliance and a respectful, inclusive workplace.</li><li>Design and implement talent development initiatives including stretch assignments, mentoring, and targeted training programs.</li><li>Lead HR project management efforts related to workforce transitions, organizational change, and process improvement initiatives.</li><li>Collaborate with cross-functional partners to deliver high-impact HR initiatives, ensuring clear communication, risk management, and timely execution.</li><li>Develop and manage detailed project plans for HR initiatives, including milestones, communications, and risk mitigation strategies.</li></ul> Requirements: <ul><li>Bachelor’s or Master`s degree in business, Human Resource Management, Psychology, or any related field 10+ years of progressive, international, HR related experience; breadth of HR knowledge and skills in a variety of fields in international context, including Business Partner; Experience in a manufacturing and or operations environment is strongly preferred.</li><li>Executive level and leadership experience; Experience influencing without authority.</li><li>Ability to influence, lead and drive execution into the functions/region through close partnership and collaboration with the broader HR function Proved track record in Organization Design, Change Leadership, Talent Management, and Organizational Development Ability to multi-task and work efficiently in a fast-paced, international matrix organization.</li><li>Preferred: Experience supporting M&amp;A activities, including HR due diligence, integration planning, and workforce impact assessments.</li><li>Strong project management and organizational skills Fluent English language skills Has advanced knowledge of regional labor laws and obligations and uses this knowledge to advise management, especially in conflict situations Excellent interpersonal, negotiation, and communication Ability to travel up to 10%</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>

Role Description: <ul><li>The position is to manage Production, Quality &amp; Delivery on time Working with ME &amp; Technician team to Implement Kaizen / Poka-Yoke technics in production line to improve productivity and quality, Push or guide operators to achieve set line targets</li></ul> Responsibilities:&nbsp; <ul><li>Maintain Shop discipline, Absenteeism, unnecessary movements of operators.</li><li>Responsible for Production, Quality &amp; Delivery on time.</li><li>Allotment of work for operators.</li><li>Ensure Material availability for present &amp; next PO.</li><li>Optimum utilization of human resources.</li><li>Overtime work recommendation/planning during production criticality.</li><li>Ensure housekeeping of M/c’s &amp; Work centres.</li><li>Ensure Material variances within specified limit.</li><li>Return of in-process &amp; by-product scrap.</li><li>Timely closure of NCAs</li></ul> Requirements&nbsp; <ul><li>Experience in BE / Diploma in mechanical Engineering.&nbsp;</li><li>Require 3+ years’ experience.&nbsp;</li><li>Hands on Experience on SAP&nbsp;</li><li>Should have knowledge on reading &amp; understanding the drawings&nbsp;&nbsp;</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>

Responsibilities: Supplier Management &amp; Development: <ul><li>Identify, evaluate, and onboard new suppliers to support business requirements.</li><li>Conduct supplier audits and performance assessments to ensure quality and reliability.</li><li>Develop and maintain strong supplier relationships to improve lead times, cost, and supply chain efficiency.&nbsp;</li></ul> Cost Management &amp; Negotiation: <ul><li>Analyze cost structures and negotiate favorable terms for materials and components.</li><li>Support cost-reduction initiatives through competitive bidding, alternative sourcing, and value engineering.</li><li>Collaborate with finance and procurement teams to optimize the sourcing budget.</li></ul> Technical &amp; Cross-Functional Collaboration: <ul><li>Work closely with engineering, R&amp;D, and manufacturing teams to define sourcing requirements.</li><li>Ensure suppliers meet technical specifications and quality standards.</li><li>Support new product development by identifying suitable suppliers for prototypes and production.&nbsp;</li></ul> Supply Chain Optimization &amp; Risk Mitigation: <ul><li>Monitor market trends and risks to ensure a stable and competitive supply chain.</li><li>Develop strategies to mitigate supplier risks related to quality, pricing, and geopolitical factors.</li><li>Optimize sourcing strategies to reduce lead times and ensure on-time delivery.</li></ul> Requirements: Required Qualifications &amp; Skills: Education &amp; Experience: <ul><li>Bachelor’s degree in mechanical engineering, Electrical Engineering, Supply Chain Management, or a related field.</li><li>5+ years of experience in sourcing, procurement, or supplier management (preferably in automotive, electronics, or manufacturing industries).</li></ul> Technical &amp; Soft Skills: <ul><li>Strong negotiation and analytical skills.</li><li>Experience in working with SAP systems and sourcing tools.</li><li>Knowledge of supplier qualification processes, cost analysis, and risk assessment.</li><li>Familiarity with engineering drawings, specifications, and manufacturing processes.</li><li>Excellent communication, stakeholder management, and problem-solving abilities.</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>

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114 improvement methodology Jobs found

Senior Quality & Reliability Engineer

Finance Business Partner

QE Specialist

Supv III Customer Service

HR Business Partner IV

Operations Manager

Assembly Supervisor

Quality Engineer

Strategic Sourcing Analyst

Associate, Quality Assurance (QMS)

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Skills

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114 improvement methodology Jobs found

Senior Quality & Reliability Engineer

Finance Business Partner

QE Specialist

Supv III Customer Service

HR Business Partner IV

Operations Manager

Assembly Supervisor

Quality Engineer

Strategic Sourcing Analyst

Associate, Quality Assurance (QMS)

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.