Senior Quality & Reliability Engineer

Associate, Quality Assurance (QMS)

124480 Quality System 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>

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>

Responsibilities: <ul><li>Drive quality policy to improve quality awareness, such as QMS training etc.</li><li>Improve quality system implementation&nbsp;</li><li>Prepare for yearly IATF16949 external audit and customer audits&nbsp;</li><li>Organize internal quality system audit. Review and summarize internal audit results to QS supervisor.</li><li>LPA development, internal process audit;&nbsp;</li><li>Follow up and verify the actions for all NC findings</li><li>Well Document Control in the company&nbsp;</li><li>Support management review</li><li>Continual Improvement Action</li></ul> Requirements: Education:&nbsp; <ul><li>Bachelor degree or above in Mechanical, Electronics or relevant&nbsp;</li></ul> Qualification &amp; Certification: <ul><li>IATF 16949 internal auditor;</li><li>APQP, PPAP, FMEA, SPC, MSA certification;</li><li>VDA6.3 internal auditor/authorized auditor</li><li>Experience: More than 5 years of working experience in quality system management, Automotive experience must be.&nbsp;</li></ul> Technical Skill &amp; Competencies: <ul><li>APQP, PPAP, FMEA, SPC, MSA,8D.&nbsp;</li><li>Process audit and product audit skills;</li><li>Familiar with ISO9001, IATF16949;</li><li>Familiar with automotive process and risk management method;</li><li>Proficient in written and oral English;</li><li>Good communication skill, integrity, accountability, logical, self-motivated, ability to work under pressure;</li><li>Good audit and problem-solving skill.</li><li>Understanding the basic HSPM related requirements</li></ul>

Skills

Industry

Location

Jobtitle

3 qms Jobs found

Senior Quality & Reliability Engineer

Associate, Quality Assurance (QMS)

124480 Quality System 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

3 qms Jobs found

Senior Quality & Reliability Engineer

Associate, Quality Assurance (QMS)

124480 Quality System 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.