Quality Engineer

Company: NuVasive
Location: Memphis
Posted on: February 15, 2020

Job Description:

Quality Engineer US, US, TN - Memphis Minimum Level of Education Required: Bachelors Degree Percentage of Travel: Up to 10% Location: TN - Memphis Ref#: Job Description - Perform all aspects of ethylene oxide (EO/EtO) sterile product release including ensuring part numbers are on the bioburden monitoring schedule, review of sterilization certification to ensure processing parameters meet validated parameters and review of biological indicator (BI) results and compiling with supplier DHRs. - Perform all aspects of gamma/e-beam sterile product release including: ensuring part numbers are active on the dose audit schedule and review of sterilization certification to ensure dose was within the validated dose ranges. - Supporting sustaining functions of sterile release program including annual validations, adoptions, drafting new protocols. - Lead the development of adequate inspection criteria. Identify the need for custom gaging for NuVasive 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 remote NuVasive sites. - Evaluate product changes for qualification and validation requirements and assist in change implementation. - 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. - 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. - 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 a re relevant to the interest of NuVasive. - Support other work of the Q.E. Department, as required. Basic Qualifications - Bachelor's degree in an Engineering discipline (e.g. BSIE, BSME, BSEE, BSBME, or BSCSE) - 3 years minimum experience in a regulated environment in Quality Engineering, Assurance and or Manufacturing/Engineering environment required (QSR, ISO 13485, and the MDD)Preferred Qualifications - ASQ CQE (Certified Quality Engineer) - Medical Device Development, Quality Engineering, Validation experience; Sterile Packaging experience; Mechanical Print Interpretation and GD & TNuVasive 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, age, 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's EEO policy is available here. About NuVasiveNuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, 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 more than $1 billion in revenues, NuVasive has approximately 2,600 employees and operates in more than 50 countries serving surgeons, hospitals and patients. For more information, please visit .

Keywords: NuVasive, Memphis , Quality Engineer, Engineering , Memphis, Tennessee