Greatbatch Medical, located in Plymouth, MN, is a leading OEM supplier of stimulation leads, advanced delivery systems and venous introducers to the CRM and Neuromodulation markets. We are currently seeking a Sr. Labeling Quality Technician with experience in supporting manufacturing. The primary purpose of this position is to plan and assure that Plant Operation deliverables and risk management activities are executed. The Quality Technician will identify and evaluate procedures and process equipment required to produce a quality product.
Essential functions/activities include :
- Revise and create labels using different software formats within change control process.
- Ensure that label/IFU meets all customer and international regulatory harmonized conformity requirements
- Coordinate changes to labels and IFUs to ensure that documentation is in compliance with FDA and ISO regulations .
- Assist labeling QE in the implementation of the new GS1 labeling requirements.
- Lead the effort to develop a process for controlling the printing and issuance of labels.
- Drive continuous improvements in GBM label change and control process.
- Provide labeling technical support to manufacturing operations on a daily basis.
- Maintain baseline information on work center quality metrics (e.g. scrap, rework, etc.).
- Develops new approaches to complex problems and can advance technology beyond previous achieved levels.
- Assess multiple production processes with skills to identify best practices to enhance performance and improve. business processes and to resolve acute or chronic problems.
- Conducts studies to understand capability for process and/or measurement systems.
- Can independently lead cross-functional teams in coordinating labeling reviews from development to production. environments through controlled change release/change order process ending with a timely and effective completion of agreed upon goals and objectives.
- Conduct data analysis to provide information for problem resolution or process improvement.
- Qualification of product / process (PFMEA, Validations, etc).
- Disposition of non-conforming material.
- Development of methodology for process monitoring and control.
- Support Special Projects/Organizational Initiatives as needed.
- Education/Experience: Bachelor’s degree preferred with a minimum 0-3 years of experience OR Associate’s technical degree with 7-10 years of experience. Experience using Loftware, EtQ, Oracle preferred.
- Specialized knowledge needed for performance of job: Computer skills as required by stated accountabilities, including advanced spreadsheet skills. Excellent problem solving skills. Excellent Communication skills are required. ISO 13485 and 21 CFR 820 experience preferred
- Special Skills:
- Strong written and verbal communication skills.
- Ability to effectively work with all levels of the organization.
- Quality mindset applied to all activities with applied understanding of ISO13485 and FDA 21 CFR 820 requirements.
- Detail and results oriented with demonstrated ability in applying rigorous problem solving techniques to highly complex labeling problems.
- Excellence in managing multiple projects and meeting multiple project deliverables on time within a fast paced high energy environment.
- Proficiency in understanding and application of international standards EN ISO 13485, EN 980, ISO/IEC 15223, EN1041, ISO 7000, IEC/TR/60878, ISO 639-1 and GS1 global standards
- Understanding and applied knowledge of risk management processes and analysis, EN ISO 14971
Greatbatch - 21 months ago