Quality Engineer

JOB SUMMARY:** This role is responsible for executing qualityengineering activities. The position ensures that products meet internalspecifications, customer requirements, and regulatory standards throughrobust inspection, process control, and quality system oversight. Theindividual will lead problem-solving efforts, manage QC operations, andsupport continuous improvement initiatives across manufacturing.QUALITY ENGINEERING DUTIES:** - Participate in validations (IQ/OQ/PQ)And Process Qualifications - Conduct Capability Studies, SPC Monitoring,and data analysis to identify trends and improvement opportunities -Develop control plans, perform risk analysis FMEAs, inspectioninstructions, and gage control practices (calibration, R&R / TMV). -Investigate production quality issues, perform root cause analysis, andcoordinate corrective actions - Lead and maintain change controlefforts - Conduct layered process audits and support internal/externalaudits - Develop, manage, and improve the facility\'s Quality ManagementSystem, ensuring compliance with ISO 9001 or customer-specificstandards. - Maintain and update quality assurance procedures,documentation, and inspection standards for injection moldingoperations - Implement proactive and reactive quality measures to reducedefects, improve process efficiency, and control variation - Serve asthe main point of contact for customer quality issues - Manage customercomplaints, documentation, and resolution activities - Train, mentor,and support quality and production staff to ensure understanding ofstandards, inspection methods, and best practices **EXPERIENCE, SKILLS,EDUCATION AND TRAINING: QUALIFICATIONS (Education/Experience/Knowledge,Skills & Abilities)** - Bachelor\'s Degree or equivalent, or 3-5 years\'related experience and/or training, or equivalent combination ofeducation and experience in quality engineering in the medicalindustry - Experience working in regulated manufacturing environments -Knowledge of cleanroom practices - Strong understanding of regulatoryrequirements and industry standards (e.g., FDA QMSR, ISO 9001). -Thorough knowledge of quality management systems, material inspectionmethods, and root-cause analysis/problem-solving tools. - Proficiency inGD&T interpretation, statistical analysis, and sampling techniques. -Skilled in the use of measurement tools including calipers, micrometers,vision systems, and CMMs. - Strong working knowledge of PPAP, FMEA,control plans, SPC, and CAPA documentation and processes. - Experienceleading or contributing to CAPA investigations and corrective actionactivities. - Ability to work with a high volume of documents in afast-paced environment - Ability to communicate effectively with alllevels of staff and management, both internal and external - Strongleadership, communication, and analytical skills - Collaborate withcross-functional teams - Strong Computer skills; Microsoft Office (Word,Excel) and Minitab **WORKING CONDITIONS:** Works under generalsupervision. Requires light physical activity performing non-strenuousdaily activities. - Must be able to lift up to 25 lbs. - Must be able tosit or stand for long periods of time - Must be able to climb up anddown stairs - Travel is required to support company initiatives **NOTE:This job description is not intended to be an exhaustive list of allPossible Duties, Responsibilities And Or Qualifications. Other Duties,responsibilities and/or qualifications may be assigned to thisposition.**