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Quality Engineer

  • Anywhere

Company :
NuVasive

Location :
San Diego, California

Expiry Date :
Mon, 07 Dec 2020 23:59:59 GMT

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Description :
Job_Summary_And_Primary_Responsibilities NuVasive is looking for a Quality Engineer that is passionate about new product design, development, launch, and maintenance of various spine/orthopedic devices. The candidate we re looking for must be highly collaborative, very organized, accustomed to a fast-paced environment, and a very creative & intelligent problem-solver and someone that can be relied upon to serve the needs of their team and our customers on a daily basis. * Develop Quality Plans for new product development initiatives * Lead the development of adequate inspection criteria. Identify the need for custom gauging for NuVasive and suppliers * Review design prints for design for inspection feedback * Support transfer of design to contract manufacturer, including the establishment of inspection plans both at NuVasive and at the supplier, reviewing process validations and analyzing measurement system analysis * Evaluate product changes for qualification and validation requirements and assist in change implementations * Support Design Control activities such as review of verification and validation test protocols and reports, contribute to risk management plan generation, review tolerance analysis, review product requirements documents, etc * Participate in quality system improvements, procedure updates, and improve the quality and reliability of products * Generate Non-Conformance reports and carry out the root cause investigation, containment of product, risk assessment and follow up action items with involvement from development, regulatory and supply chain * 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 * Required_Skills_/_Capabilities * Mechanical Print Interpretation and understanding of GD&T * Education_And_Experience * Bachelor’s degree in an engineering discipline (e.g. BSIE, BSME, BSEE, BSBME, or BSCSE) * Three 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) preferred * Experience utilizing statistical methods to justify sampling requirements of product inspection and acceptance criteria of various design verification testing * 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, 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_NuVasive NuVasive, 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 . Show moreShow less