| Job Description | ESSENTIAL JOB FUNCTIONS
Responsible for evaluating equipment, processes and procedures to ensure manufacturing processes and equipment operate in compliance and create conforming spinal implants.
Ensure all systems and processes have approved procedures that are appropriate to control the validated process.
Ensure that the ongoing performance is within the expected output of the existing process validation and that manufacturing equipment and processes stay under the validated state.
Maintain and execute Master Validation Plans.
Develop test protocols, execute validations according to the protocol, document validation activities in test reports. This will include developing validation procedures, work instructions, forms and standards.
Manage local validation activities of equipment and support global validation activities as needed. Activities may include, but not be limited to: equipment, process, software and products.
DUTIES AND RESPONSIBILITIES
Document test results and maintain records, compose reports, improve and/or adjust processes, read or interpret drawings including complex callouts and GDT.
Evaluate product changes for qualification, and validation requirements and assist in change implementations.
Support process control activities such as Risk Assessment, quality plans, Gage R&R, verification/validation activities and process capability analysis.
Qualify and manage subcontract supply base, including on-site audits, quality agreements, corrective actions and validations.
Develop new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products.
Support non-conforming material program.
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires Bachelor’s degree in an engineering related discipline (e.g. BSIE, BSME, BSEE, or BSBME).
5+ years direct experience in a regulated environment in Quality Assurance and /or Manufacturing / Engineering environment that included ISO 13485, QSR and MDD.
Computer Skills:
Proficient and accurate with word processing (Word).
Spreadsheets charting, flow charting, and graphs. (Excel).
Knowledge of statistical software package such as minitab or statgraphics (or equivalent) is highly desireable
Competency in navigating the Internet.
Language Skills:
Ability to read and interpret documents such as safety rules, company policy and procedure manuals.
Ability to write business reports and correspondence.
Ability to speak effectively before groups of customers, employees, and management of organization.
Mathematical Skills:
Strong mathematical skills, including statistics (significance tests, determination of confidence/reliability, normality assessments, sample size selection, process capability and knowledge of production sampling plans).
Reasoning Ability:
Ability to solve and interpret problems, collect data, establish facts, and draw valid conclusions.
Nancy Vance
Manager - Talent Acquisition
Tessa Dolkas
Sr Talent Acquisition Coordinator
Wendy Harrison
Associate Recruiter
Lucas Vitale
VP Talent Acquisition |
| | Company | | NuVasive, Inc. | Job Code | | State or Province | | Ohio | | |
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