Senior Quality Engineer
US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: OH - West Carrollton
The Senior Quality Engineer is responsible for the development, implementation, and improvement of manufacturing quality plans. They will participate in Production and Process Control activities and provide guidance to Process Development. They will also support quality system and production processes by developing inspection/testing plans, performing risk analysis and developing process validation protocols and reports to ensure the quality of new and modified products and processes in a CNC Manufacturing environment.
- Supporting process development and production transfer activities.
- Quality planning: establish and implement timely risk analysis, control plans, and inspection plans for in-process and final inspection. Enlists appropriate engineering or technical assistance to develop adequate inspection criteria, if needed. Performs inspections as needed, or ensures that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action. Identify opportunities, coordinates development of criteria and documentation, to facilitate suppliers’ performance of quality inspections
- Design and procure production gaging when appropriate.
- Evaluate and qualify manufacturing processes to ensure technical requirements can be met. (MSA, Cpk, assembly validation ,etc) Provide process development and operations with inspection criteria prior to manufacturing. Manage process validations and process improvements
- Plan, execute, and respond to QMS documents and problem resolution
- Manage corrective actions, rework plans, deviations, and non-conformances. Issues corrective actions and drives root cause investigation and corrective action implementation. Sr. QE is responsible for timely resolution of discrepant materials.
- Assist CAPA program with analysis and efforts relative to product quality issues. Identify and trend quality issues. Support analysis of CAPA Program data and identify/trend quality issues.
- Plan, execute and ensure department goals and objectives are met
- Train, guide, influence and mentor Jr. or new Quality Engineers
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485, 21 CFR 820, and the European Medical Device Directive.
- Bachelor’s degree or comparable experience in a business, science, technical, or engineering discipline (e.g. BSIE, BSME, BSEE, or BSBME).
- Five years minimum experience in a regulated manufacturing environment in Quality Engineering and / or Manufacturing Engineering required (21 CFR 820, ISO 13485)
- Expertise in interpreting and applying GD&T
- Proficient and accurate with word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs. Competency in navigating the Internet
- Experience in electronic QMS and ERP systems
- Strong mathematical skills, including statistics. (Tolerance analysis, significance tests, process capability, sampling plans, GD&T)
- American Society for Quality Certified Engineer (CQE)
- Strong understand of ISO 13485, CFR 21 820, and/or MDR
- Strong manufacturing background
- Clean room experience
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 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 www.nuvasive.com.