PrinterPrezz is a workplace where people from different aspects of life come together to create an unstoppable team. With strong values, connections and progressive attitudes we make sure everyone feels their best. Being greeted with a fluffy face and wagging tail also helps.
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- Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and report
- Ensure stabilization of new product launches through steady-state processes.
- Monitor the continuous improvement of product requirements, verification strategies, and validation strategies across design and manufacturing changes.
- Support design and process changes throughout commercialization of product lives
- Ensures continued product development compliance with FDA QSR (21 CFR 820), ISO 13485:2016, MDSAP, and other applicable regulations
- Activities would drive prevention, detection of defects to improve/stabilize product launches, continuous improvement & customer satisfaction.
- Provide statistical support, expertise and analytical problem solving for sustaining activities, including development and manufacturing.
- Works directly with internal customers, design, manufacturing and other groups to develop appropriate equipment specifications for calibration and preventative maintenance (PM), such as parameters, intervals, tolerances, acceptance criteria and operating limits for new and existing equipment and systems.
- Ensures inspection and sampling plans, test methods, and transfer functions for products and components are in place and working accordingly
- Participates in investigations of non-conformances, driving consistencies in manufacturing and design
- Contributes to CAPA investigations and solution verification
- Executes projects and assignments with technical responsibility
- Supports the Risk Management process per ISO 14971 and construction / maintenance of the Risk Management File.
- Support the implementation of quality management system (QMS) documentation to ensure compliance with the quality manual and associated Regulations and Standard Operating Procedures (SOPs).
- Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices
- Perform DHF/DHR review for product release.
- Ensures outside supplier quality systems meet requirements and coordinates any activities with the supplier as needed
- Participate in internal, third party and customer audits.
- Assist the Quality Department with other applicable tasks as assigned.
- Bachelor’s degree with 3-5 years of related experience
- Experience working in a cross-functional team environment
- Proficient technical writing skills and use of documentation programs (GoogleDocs, GoogleSheets etc.).
- Working knowledge of fundamental quality and statistical tools and familiarity with a statistical software package (Minitab, JMP, SAS, SPSS, etc.)
- Familiarity with FDA QSR, and ISO 13485 medical device regulations and standards (required); MDSAP (preferred)
- Certified ISO 13485 Lead Auditor a plus