US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: No travel required
Location: OH - West Carrollton
- Develop Quality Plans for the product development team.
- Lead the development of adequate inspection criteria. Identify the need for custom gaging for NuVasive and suppliers.
- Identify and qualify equipment required to perform inspection.
- Support transfer of design to contract manufacturer, including establishment of inspection plans both at NuVasive and at the supplier.
- Evaluate product changes for qualification and validation requirements and assist in change implementations.
- Establish and implement systems to ensure timely quality inspections for incoming materials, components or finished goods products. Work with engineering to develop adequate inspection criteria. Perform inspections as needed, or ensure that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action.
- Support Design Control activities such as Risk Assessment, supplier quality plans, design verification and design validation and sterilization/packaging validation.
- Qualify and manage subcontract supply base, including on site audits, quality agreements, corrective actions and 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.
- Conduct investigations, initiate or process actions from quality system feedback information (records review, acceptance activities, non-conforming materials reports, corrective action reports, complaints, and audit reports) as needed.
- 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.
- Other functions include:
- Review technical publications, articles, and abstracts to develop applicable skills and to stay abreast of quality, regulatory, compliance, and technical developments in the industry.
- Attend such conferences, seminars, professional meetings, and other public forums as are relevant to the interests of NuVasive.
- Support other work of the Q.E. Department, as required.
- Bachelor's degree in an engineering discipline (e.g. BSIE, BSME, BSEE, BSBME, or BSCSE).
- One year 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.