JO – 4093 Quality Engineer Implantable Medical Devices
Quality Engineer Implantable Medical Devices
Provide quality support to customers, suppliers, manufacturing engineers, inspection and production personnel to ensure products and processes conform to customer and regulatory requirements. Generate and maintain metrics to identify continual improvement opportunities. Job Duties and Responsibilities (Essential Functions) Collect, review, analyze and publish corrective action and non-conformance data in an effort to eliminate non-conformances. Develop and maintain working relationships with Engineering, Quality Systems, Inspection and Manufacturing personnel to facilitate group problem solving and cooperation.
Understand and provide support for quality requirements as needed including, certificates of conformance, sampling inspections, first articles inspections, process approval, inspection plans, test and inspection reports, PFEMA, and control plans. • Support the completion and maintenance of risk analysis and complaint evaluations. • Lead the investigation to resolve customer complaints and in the prevention of product non conformances. • Develop reports and metrics on various aspects of product assurance function including the cost of scrap and rework operations, the accuracy of inspection, quality of outgoing product, etc. Monitor nonconforming parts through RMA and the rework process including timely disposition and closure. • Support the auditing and evaluation process to assure conformance to established standards, specifications, and customer requirements. • Prepare reports and make recommendations for corrective or preventative action to improvement product quality. Implement action to be taken and follow up for effectiveness to eliminate or prevent non conformances and their causes. • Assist with the development of inspection processes and operation instructions • Assist 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 the 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.• Understanding of internal auditing methods and quality system procedures.• Understanding of Process Failure Mode Effect Analysis and control plan.• Working knowledge of quality at the source techniques, root cause analysis, corrective action, continuous improvement.• Ability to interpret engineering drawings.• Strong organizational and project management skills. • Ability to understand quality issues and assist staff in root cause problem solving 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 the product. Additional Skills and Experience (Preferred or helpful)• Experience working in the Medical Device industry, specifically ISO 13485:2016 and FDA 21 CFR 820.• ASQ Certified CCT preferred or CQE desired or willing to obtain.• Familiar with ANSI/NCSL Z540-01 and ISOIEC17025 a plus.• Experience working with M1 ERP system or similar• Ability to work well with little supervision• Must be a well-organized problem solver.• Possess the ability to make rational knowledge-based decisions.