US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: CA - San Diego
The Quality Engineer is responsible for design control deliverables, development/implementation of inspection criteria and occasional supplier quality management. The QE is responsible for the development, implementation, and improvement of overall quality systems, including quality standards, test methods, process control techniques, and inspection/testing plans to ensure safety, reliability, and efficacy of new and modified products and processes.
Essential Duties and Responsibilities:
- Establish and implement systems to ensure timely quality inspections for incoming materials, components or finished goods products. Enlists appropriate engineering or technical assistance to develop adequate inspection criteria, if needed. Performs inspections as needed, or ensures that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action. Identify opportunities, coordinates development of criteria and documentation, to facilitate suppliers’ performance of quality inspections.
- Contribute to Design Control activities such as specification development, design verification and validation and audit of DHFs. Lead Risk Management activities. Develop and review Sterilization, Packaging, and Equipment Validations.
- Develop new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products
- Support Non-Conforming Material Program.
- Assist CAPA program with analysis and efforts relative to product quality issues. Identify and trend quality issues. Support analysis of CAPA Program data and identify/trend quality issues.
- Evaluate and qualify Suppliers to ensure technical and quality requirements can be met. Manage corrective actions, rework plans and non-conformances. Provide suppliers with inspection criteria prior to manufacturing. Manage process validations and process improvements.
- Support the analysis and presentation of information to executive management concerning measures of product and service quality, supplier performance, manufacturing problems, and design issues as identified through various quality systems program elements.
- Bachelor's degree in an engineering discipline (e.g. BSIE, BSME, BSEE, BSBME, or BSCSE).
- Two years minimum experience in a regulated environment in Quality Engineering, Assurance and or Manufacturing / Engineering (design) environment required (QSR, ISO 13485, and the MDD). American Society for Quality Certified Engineer (CQE) desirable.
- ASQ CQE (certified quality engineer)
- Medical Device Development, Quality Engineering, Validation experience; Sterile Packaging experience; Mechanical Print Interpretation and GD&T
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.