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Validation Engineer
Philadelphia, PA
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Job Description Our client is seeking a Quality Engineer at our manufacturing site in Philadelphia, PA. The shift time is 7am-4pm Monday-Friday.
The Quality Engineer is responsible for ensuring that products, processes, and systems comply with internal quality standards as well as customer, regulatory, and industry requirements. This role works closely with Quality Control and Manufacturing teams to drive continuous improvement, minimize defects, and resolve quality issues through structured, data-driven problem-solving approaches.
What You Will Do:
Develop, implement, and maintain quality systems, tools, and procedures to support product and process quality objectives.
Lead root cause analysis and corrective and preventive action (CAPA) activities related to nonconformances, customer complaints, and internal findings.
Support New Product Introduction (NPI) activities, including risk assessments (FMEA), control plan development, and validation efforts.
Conduct and support internal, supplier, and customer audits to ensure compliance with applicable quality standards and regulatory requirements.
Collect, analyze, and interpret quality data and metrics to identify trends, risks, and opportunities for improvement.
Collaborate with cross-functional teams to drive continuous improvement initiatives using Lean, Six Sigma, or related methodologies.
Review and approve engineering changes, specifications, and work instructions from a quality perspective.
Provide quality guidance and support to manufacturing operations, suppliers, and external partners.
Ensure effective document control and adherence to electronic Quality Management System (eQMS) requirements.
Extended hours may be needed due to business situation.
Support customer interactions related to quality performance, investigations, and corrective actions
Minimum Qualifications:
Bachelor's degree in Chemical Engineering, Chemistry, Engineering, or a related technical discipline2 years of experience in quality engineering or a related roleExperience working within a Quality Management System (e.g., ISO 9001)Proficiency with data analysis and reporting tools such as Microsoft Excel, statistical software, or quality systemsImmigration sponsorship is not available for this role
Preferred Qualifications:
Strong working knowledge of quality tools and methodologies, including FMEA, SPC, MSA, Control Plans, and Root Cause Analysis techniques (e.g., 5 Whys, Fishbone)Working knowledge of SAPSix Sigma Green Belt or Black Belt certification, or Lead Auditor certificationExperience in regulated industries such as medical devices, automotive, aerospace, or pharmaceuticalsFamiliarity with risk management and process or product validation activitiesStrong analytical and problem-solving skillsExcellent written and verbal communication abilitiesAbility to collaborate across functions and influence outcomes without direct authorityDetail-oriented mindset with a strong focus on quality and continuous improvement Skills and Requirements Bachelor's degree in Chemical Engineering, Chemistry, Engineering, or a related technical discipline2 years of experience in quality engineering or a related roleExperience working within a Quality Management System (e.g., ISO 9001)Strong working knowledge of quality tools and methodologies, including FMEA, SPC, MSA, Control Plans, and Root Cause Analysis techniques (e.g., 5 Whys, Fishbone)Working knowledge of SAPSix Sigma Green Belt or Black Belt certification, or Lead Auditor certificationExperience in regulated industries such as medical devices, automotive, aerospace, or pharmaceuticals We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.