MOS is always looking for passionate people to join our team. If you are interested in working for us, please send your resume and a cover letter to firstname.lastname@example.org.
Industrial Quality Engineering Technologist:
Plan and coordinate quality programs and activities to ensure the quality and reliability of medical products.
Develop and/ or monitor quality plans and quality engineering tasks, as well as, manufacturing process validations and controls to ensure compliance with established requirements and regulatory expectations.
Interact with customers in resolving any quality issues and communicates it internally to ensure that customer specifications and requirements are met.
Provides statistical analysis for quality improvement by data collection, CAPA analysis and defining testing methods.
Key contact person for major medical customers, in resolving any quality issues, improvements to existing products. Perform CAPA and SCAR investigations in a timely manner for product and process issues to ensure ongoing compliance with internal specifications and regulatory requirements.
Work with QA Manager to develop & execute plans (quality plans, risk management plan) and product requirements, to ensure provisions for quality are addressed and resolved prior to product shipment.
Develop, qualify/certify, and maintain supplier quality development and perform supplier audits.
Resolve any quality, test, and certification requirements in cooperation with customer and supplier to assure customer drawings/ specifications are met.
Promote compliance with company procedures and regulatory requirements for medical device manufacturing.
Compile and institute quality metrics to trend, recommend and implement corrective actions and appropriate follow-up when necessary.
Lead and/or participate in complaint investigations, failure analysis of returned products, and issues resulting in stop ship/ stop production.
Document findings, provide reports and analysis.
Provide validation support by applying manufacturing quality tools including, but not limited to: FMEA, IQ, OQ, PQ & Control Plans.
Work with manufacturing to coordinate and monitor production processes to ensure compliance to ISO 9001, ISO 13485 and other applicable regulatory requirements.
Participate in MRB (Material Review Board) to review and disposition non conformities and to work with manufacturing and customer to coordinate corrective actions.
REQUIREMENTS: Master’s degree in Mechanical Engineering or related plus 1 year of experience as a Quality Engineering Technologist, Quality Control Engineer, or related or a Bachelor’s degree in Mechanical Engineering or related plus 5 years’ experience as a Quality Engineering Technologist, Quality Control Engineer, or related. Requires 1 year of experience working in quality control in an ISO or FDA regulated industry, with ISO standards, with quality management systems and auditing, reading drawings and GD&T, with root cause analysis, CAPA implementation and risk management, CMM programming and with inspection instruments (Calipers, micrometers, height gage, etc). Resume to HR at 2116 Farallon Drive, San Leandro, CA 94577.”