JO – 4027 Quality Engineer
Quality Engineer position:
Provides quality assurance and control support to customers, suppliers, and internal production to ensure products, components, parts, and material conform to customer, supplier, and regulatory requirements. Partner with the Manufacturing Engineer and provide quality support. Job Duties and Responsibilities (Essential Functions)• Review and analyze corrective action and non-conformance data in an effort to eliminate non-conformances.
• Support quality requirements including, certificates of conformance, sampling inspections, first articles inspections, process approval, inspection plans, test and inspection reports, PFMEA, and control plans. • Support the completion and maintenance of risk analysis and complaint evaluations. Lead the investigation, resolution and prevention of product non-conformances. Support validations and leverage verification over validations, if applicable. • Develops reports and metrics on various aspects of product assurance function including cost of scrap and rework operations, accuracy of inspection, quality of outgoing product, etc. Monitor nonconforming parts through RMA and the rework process including timely disposition and closure. • Supports the auditing and evaluation of to assure conformance to established standards, specifications and customer requirements.
Prepares reports and makes recommendation to appropriate sections for corrective or preventative action to improvement in product quality and/or reliability. Implement action to be taken and follow up for effectiveness to eliminate or prevent nonconformance and their cause. • Participate with product process what records to be used to measure results, what specific measuring instruments and equipment is required, and specific instructions associated with operation. • Assist in proper execution of the internal audit program to measure the overall effectiveness of the quality management system.
Required Skills and Experience (Minimum requirements in terms of educational background, work experience, licenses/certifications or other knowledge, skills, and abilities).• Bachelor’s degree in Engineering or related discipline.• Minimum 5 years of experience in a related role and industry sector.• Proficient reading, writing, oral communication, and comprehension in English language. • Knowledge of industrial math.• Knowledge and working experience with MS Office, (Word, Excel, Power-Point, Project). Knowledge of computer integrated manufacturing software including accessing and retrieving information using the computer. • Expertise with data and defect analysis, variance reduction, and capability analysis.• Strong knowledge in the application of Quality Systems.• Comprehensive knowledge of internal auditing methods and quality system procedures.• Understanding of Process Failure Mode Effect Analysis and control plan.• Comprehensive knowledge of quality at the source techniques, root cause analysis, corrective action, continuous improvement.• Demonstrated ability to interpret engineering drawings.• Strong organizational and project management skills.
• Ability to quickly grasp the complexities of disparate quality issues and assist staff in solving quality issues to effectively meet customer needs.• Strong interpersonal skills and demonstrated ability to work effectively within the organization and collaborate with internal and external clients to determine requirements and eliminate any barriers that may affect the quality and delivery of product. Additional Skills and Experience (Preferred or helpful)• Experience working with the Medical or other highly regulated industry, specifically ISO 13485:2016 and FDA 21 CFR 820.• ASQ Certified CCT preferred or CQT desired.• Bachelor’s degree in Engineering or related discipline.• Familiar with ANSI/NCSL Z540-01 and ISOIEC17025 a plus.• Experience working with M! ERP system or similar• Ability to work well under pressure and with little supervision• Must be a well-organized problem solver.• Possess the ability to make rational knowledge-based decisions.