Quality Technician (Temp)
Position Overview
Provide integral support to the Quality and Manufacturing teams by ensuring incoming materials and finished products meet the established quality standards and world-wide regulatory requirements. Ability to handle the completion of a diverse set of projects and tasks required. Job duties:
- Ensure conformance to quality systems with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485-2003, Canadian Medical Device Requirements (CMDR) MDD 93/42 EEC and other applicable international standards and regulations.
- Perform complex mechanical, dimensional, and first article inspections of incoming components, raw materials, in-process products/sub-assemblies and finished goods. Assist with monitoring the SPC controls on the production floor.
- Manage the calibration program including scheduling, interfacing with outside services, review of certifications, and maintenance of files. Provide review and approval of preventative maintenance work orders.
- Responsible for related paper and electronic record keeping associated with all inspections, including, but not limited to, part numbers, lot numbers, quantities, inspection results, inspection dates.
- Provide a quality control review and release function for Device History Records and Sterile load releases.
- Support Quality Engineering and Operations in the development and execution of internal test methods, including use of various complex equipment and fixtures.
- Provide leadership and training to the QC and RI inspectors.
- Notify Management in the event of a nonconformance, noncompliance situation.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- High school diploma or equivalent.
- Minimum three (3) years of related work experience.
- Knowledge of basic measuring techniques including scales, rulers, and US and metric measurement.
- Basic knowledge of QSR (CFR 21 820 and ISO 13485).
- Ability to follow company, quality and regulatory procedures and standards.
- Good written and verbal communication skills.
- Ability to read, write, and speak in English.
- Good laboratory or manufacturing practices and ability to follow required safety procedures.
- Ability to read and understand technical documentation.
- Basic computer skills including MS Windows, Word, Excel, Teams, Outlook, etc.
- Ability to manage several tasks and projects.
- Basic math skills.
- Knowledge of basic statistical tools and concepts a plus.
- Experience in the medical device industry.