Job Description
Quality Engineer
- Full-time, permanent position
- Rancho Cordova, Sacramento County, California, USA
Are you a seasoned Quality Engineer? Are you looking for an opportunity to join a team of experienced professionals and work for a stable and quality-focused company?
If this sounds like you, we want to hear from you!
We’re Raise, and we’ve joined forces with our client, an industry leader within the medical device sector. They specialize in the development and commercialization of automated cell processing technologies for cell and gene therapy fields.
What you’ll be doing :
As the new Quality Engineer , you’ll be responsible for executing quality assurance initiatives for medical devices in compliance with the US FDA's Medical Device Quality System Regulation (21 CFR 820), EN ISO 13485, and internal policies. It supports the design and manufacturing of electro-mechanical devices to meet quality and business goals through ongoing improvement activities. The position requires effective participation in engineering projects to ensure compliance with design, manufacturing controls, and risk management processes. It also involves analyzing quality system data, such as field complaints and nonconforming products, to identify adverse trends and opportunities for continuous improvement. Additionally, the role leads the quality operations support team, overseeing manufacturing and controls acceptance of materials from receiving through to the final product release.
Responsibilities :
Identification and traceability :
Execute the process of product and equipment identification and traceability during stages of receiving inspection, quarantine and final inspection.Production and process controls (Deviations, Equipment, Labels) :
Execute the process for control of process deviations.Execute the process for control of inspection, measurement and test equipment and work with technical resources to verify the equipment is suitable for its intended purpose.Support and troubleshoot production label operations.Acceptance activities :
Execute the process for conducting first article, receiving, and final acceptance inspections using special inspection tools and processes.Nonconforming product and process :
Manage the process for controlling nonconforming materials, assemblies or final product and processes including investigate and review nonconformance activities and generate CAPAs / SCARs based on trends / issues identified from operations, MRB and drive them to closure.Supplier Management :
Manage and maintain supplier qualification and performance monitoring program.Records :
Assure records resulting from quality operational activities are maintained, controlled and transferred to appropriate record archival locations as designated by the company Quality Policy.Complaints :
Execute Complaints review tasks as required to maintain regulatory compliance including but is not limited to :
Regulatory reporting assessment (MD / VR)Assist investigationComplaint database maintenanceManagement reporting and metricsSupport process contributorsComplaint file closure auditAudits :
Support internal and external audits. Including but is not limited to :
Audit managementDocumentation / record retrievalDatabase maintenanceCorrection and Corrective Action response to audit non-conformancesQuality Engineer :
Review change orders to ensure justification, impact level, and evidence of required activities are properly documented.Facilitate Risk Management and support Design Control activities throughout the product lifecycle.Perform internal audit to ensure effectiveness of quality system processesEnsure suppliers deliver quality parts, materials, and services by effectively qualifying and monitoring supplier performance.Uphold company compliance programs in support of government standards including FDA Quality System Regulation 21 CFR 820, ISO 13485, EN, MDD, Canadian, UL and CSA regulations.Additional Functions :
Maintain functional procedures and revise as necessary.Process tasks in accordance with company timelines.Assess and evaluate workload against agreed processing timelines.Track and trend process metrics.Escalate issues to management as necessary.Lead functional continuous improvement projectsThe Details
This is a full-time, permanent opportunity located at a state-of-the-art facility in Rancho Cordova, nestled in vibrant Sacramento County, California, USA. You'll work Monday to Friday within the facility. You’ll receive a competitive base salary starting at $80,000 per year, (commensurate with your experience). In addition to this, they offer comprehensive benefits, including health and dental coverage, a 401(k) plan, and vacation time, ensuring a balanced and rewarding career.
Qualifications
Four-year B.S degree in Mechanical Engineering or Electrical engineering preferred. High School diploma with relevant trade school or college level courses in a related area would be consideredMinimum 3 years’ experience in a medical device Quality Assurance capacityKnowledge of quality systems integrationExperience / Involvement in regulatory body audit and inspectionsExperience and knowledge of ISO 13485, 21 CFR 820 and Measurement toolsExperience in Quality Management System software, Enterprise Resource Planning systems, Microsoft Office suiteExperience with technical writing of manufacturing procedures, work instructions, test protocols and reportsExperience in Root Cause Analysis and Corrective Action / Preventative Action (CAPA)Product Risk Management throughout the product lifecycleStandard statistical principles, theories, concepts, and techniquesDesign ControlsProject management of process / product improvementsFailure investigations in a manufacturing environmentBlueprint reading and interpretation including Geometric Dimensioning and Tolerance (GD&T) is preferredRepresent Quality / Validation needs on multifunctional design teams and Project / Program Core TeamsHighly motivated and dedicated to Quality PrincipalsYour Application
We value diversity and inclusion and encourage all qualified people to apply; however, only those selected for an interview will be contacted.
Salary : $80,000
