The Sr. Software Quality Engineer role will perform quality engineering duties associated with new product development: design requirements and validation, design controls, quality planning, risk management, human factors engineering and establishment of appropriate manufacturing process validations and controls. Duties to be performed in compliance with applicable regulations and standards including FDA Quality System Regulation 21: CFR 820, ISO 13485, and the European Medical Device Directive.
- Design Controls/Quality System
- Participate in new product development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations. Key deliverables including, but not limited to product performance analysis on similar products, risk analysis, failure mode and effects analysis, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
- Must be knowledgeable in IEC 60601, IEC 62304 and IEC 62366
- Participate in software architecture and code review.
- Review drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer. Review and approve engineering change requests. Review product verification and validation plans and approve reports.
- Understand and apply the manufacturing quality toolset including PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gaging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC.
- Assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution. Develop control plans that identify inspection characteristics, gauging techniques, and sampling requirements. Work with manufacturing sites to resolve conflicts and recommends revisions as required.
- Conduct investigations to identify root cause of problems and implement effective corrective actions. Participate in internal audits and suppliers evaluations. Assist in the creation/revision of quality system documents.
- Assist in coaching and mentoring Jr. or new Quality Engineers
- Requires a bachelordegree in an engineering discipline (e.g. BS Software Eng, BS Computer Eng, BSME, BSEE, or BSBME).
- Strong knowledge of IEC 62304 and experience supporting both software and hardware systems
- Five years experience in a regulated medical device environment in Software Quality Engineering implementing CAPA (21 CFR 820, ISO 13485).
- Proficiency in interpreting C/C++
- Proficient and accurate with word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs. Competency in navigating the Internet.
- Strong mathematical skills, including statistics. (Tolerance analysis, significance tests, process capability, sampling plans, GD&T).
- American Society for Quality Certified Engineer (CQE) highly desirable.
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here. NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.