US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: OH - West Carrollton
Responsible for assisting in the development, validation, implementation, and improvement of overall quality systems for the cleaning, packaging, and sterilization of medical devices. Including quality standards, test methods, process control techniques, and inspection/testing plans to ensure safety, reliability, and efficiency of products and processes. Performs duties in compliance with applicable regulations and standards including FDA Quality System Regulation 21 CFR 820, ISO 13485, and the European Medical Device Directive.
- Plan and conduct complex research projects, such as improving sterilization procedures for medical devices.
- Supervise the work of technicians and other workers and evaluate the accuracy of their results
- Develop and execute Validations, Quality Plans, Standard Operating Procedures, Test protocols and Work Instructions to define and improve the cleaning sterilization process.
- Perform laboratory experiments that are used in the diagnosis.
- Identify and classify microorganisms found in specimens collected from medical devices.
- Review literature and the findings of other researchers and attend conferences
- Prepare technical reports and protocols, publish white papers, and make recommendations based on their research findings
- Present research findings to executives, engineers, other colleagues, and the public.
- Ensure proper statistical methods are applied to testing, validation, sampling, inspection, etc.
- Support continuous improvement, change management, corrective and preventative action, auditing, development of adequate inspection criteria, and coordination of validation testing as required. Evaluate process changes for qualification and validation requirements and assist in change implementations.
- Assist in the identification and qualification of equipment required to perform inspection.
- Research restricted materials in contact for medical devices. Review current systems, procedures, in processes. Develop new policies, systems, and procedures to better evaluate the risk of new materials in contact.
- Develop new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products.
- Assists 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.
- 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).
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.
- Bachelor of Science in Microbiology or related field.
- A minimum of three years’ experience in CLEAN ROOM sterilization in a pharma or medical device facility.
- Experience in a manufacturing environment.
- Proficient and accurate with Word, Excel, Outlook, IE, Adobe, Acrobat, Project and Visio.
- Ability to read, analyze, and interpret engineering standards, general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from managers, clients, customers, and the public.
- Ability to calculate figures and amounts such as probability, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry, as well as trigonometry, geometric tolerances, statistics, calculous and tolerance analysis.
- Ability to solve, and interpret problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstracts and/or concrete variables.
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 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.