Sr. Quality Engineer
US, US, CA - Aliso Viejo
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: CA - Aliso Viejo
As a Sr. Quality Engineer at NuVasive Specialized Orthopedics, you play a critical role in new product development, manufacturing implementation & associated control plans. Primary responsibilities include:
- 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.
- 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.
- Requires a bachelor degree in an engineering discipline (e.g. BS Software Eng, BS Computer Eng, BSME, BSEE, or BSBME).
- Five years minimum experience in a regulated manufacturing environment in Quality Engineering required (21 CFR 820, ISO 13485).
- 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).
- This position requires infrequent travel up to 10%.
- American Society for Quality Certified Engineer (CQE) highly desirable.
- The employee must occasionally lift and/or move up to 10 pounds.
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, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.