Manager, Quality Engineering
US, US, TN - Memphis
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: No travel required
Location: TN - Memphis
This role is responsible for the overall success of the quality engineering operation. This will include meeting and exceeding output goals, working with functional teams to improve customer fulfillment metrics, holding all shareowners accountable for fulfillment of corporate and team objectives and proper maintenance and care of company resources (i.e. Preventive Maintenance, 5S, etc.), and ensuring all shareowners are performing activities consistently and compliant to all organizational procedures and global regulatory regulations.
Essential Duties and Responsibilities:
- Manage Design Control Activities for the Quality Engineering group.
- Manage Quality Engineering systems: Non-Conforming Material Program, Deviation Program, Rework Program and Supplier Corrective Action program. Trend root cause to drive improvements both internally and externally. Maintain compliance of these systems.
- Manage and document Sterilization, Packaging, and Equipment Validations, including development of protocols, review of final reports, and review of routine sterilization audits reports.
- Supervisory Responsibilities:
- Supervises Quality Engineering. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
- Represent Quality Engineering in third party audits (FDA, Notified Bodies, etc.).
- 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:
- Performs duties in compliance with applicable regulations and standards such as FDA Quality System Regulation 21 CFR 820, 803, 1270 and 1271, ISO 13485, and the European Medical Device Directive.
- 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.
- Support development of adequate inspection criteria. Evaluate product changes for qualification and validation requirements and assist in change implementations.
- Ensure proper statistical methods are applied to testing, validation, sampling, inspection, etc.
- Support transfer of design to contract manufacturer, including establishment of quality agreements, development of adequate inspection criteria, and coordination of validation testing as required. Evaluate product changes for qualification and validation requirements and assist in change implementations.
- Assist in the identification and qualification of equipment required to perform inspection.
- Develop new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products.
- Review and approve new documents and product changes for compliance by serving on the change and design control boards.
- Coordinate and manage risk management activities.
- Requires a bachelor degree in an engineering discipline (e.g. BSIE, BSME, BSEE, or BSBME).
- Five to ten years of experience in a regulated environment (QSR, ISO 13485, and the MDD) in Quality Assurance and or Manufacturing / Engineering.
- Three to five years management experience.
- American Society for Quality Certified Engineer (CQE) desirable.
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 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 over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.