Senior Supplier Quality Engineer

US, US, CA - San Diego

Minimum Level of Education Required: Bachelors Degree

Percentage of Travel: Up to 25%

Location: CA - San Diego

Ref#: 17292

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Job Description

The Senior Supplier Quality Engineer is responsible for supplier quality management through assessment, monitoring and improvement of supplier 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.  This person will work closely with Quality Control, New Product Quality Engineering, Supply Chain and Product Development to meet specified goals and objectives. In this role, you will oversee qualifying and developing suppliers according to company standards to ensure delivery, quality and cost effectiveness; utilize a hands-on approach with monitoring suppliers’ performance and communicate and resolve supplier-related problems as they occur; develop and prioritize an auditing schedule to ensure that designated suppliers are audited and evaluated on a regular basis to ensure current good manufacturing practices (cGMPs) and quality standards are met; and evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation to management. In addition, this individual would provide leadership and guidance relative to supplier programs, assuring we maintain compliance with QSR and ISO certifications.

Essential Duties and Responsibilities:

 

1.     Evaluate and qualify suppliers to ensure technical and quality requirements can be met.  Evaluation of suppliers may be as part of due diligence in selection of new suppliers, transfer of manufacturing from one supplier to another or as part of second sourcing.

2.     Schedule, plan and lead supplier audits, including creation of audit reports and management of corrective actions related to audit non- conformances.

3.     Initiate and manage supplier corrective actions.  Expected sources include, but are not limited to, Incoming QC Non-conforming materials; Supplier Audits; Supply Chain issues (e.g. On-Time Delivery, inventory management); Product Complaints; etc. Communicate quality issues to suppliers as needed and provide assistance to develop corrective actions.  Provide technical guidance for identifying and resolving quality issues using quality tools and structured problem-solving methodologies.

4.     Evaluate and determine the internal requirements for approval of supplier change requests. Changes may support potential improvements in product quality via scrap reduction, process efficiency, or cost reduction.

5.     Support Non-Conforming Material Program and product complaint team by performing root cause investigations and product impact analysis.

6.     This role requires approximately 25% travel.

Basic Qualifications
  • Bachelor's degree in an engineering discipline (e.g. BSIE, BSME, BSEE, BSBME, or BSCSE).  
  • Five 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.
Preferred Qualifications
  • 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.

About NuVasive
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.
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