Sr. Technician, Quality Control
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.
- 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.
- 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.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), or Performance Qualification (PQ) as required and conduct related tests.
- 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.
- Contribute to failure analysis and root cause investigations of non-conformances and variances.
- Identify areas for quality control improvement and propose solutions.
- Contribute to continuous improvement initiative projects and test procedure updates.
- 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.
- Associate degree or equivalent from a two-year college or technical school.
- Minimum seven (7) 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.
- Strong written and verbal communication, organizational, and interpersonal skills.
- Proficient with MS Windows, Word, Excel, Teams, and Outlook.
- Ability to manage several tasks and projects.
- Ability to work independently with little or no supervision.
- Knowledge of basic statistical tools and concepts a plus.
- Experience in automated vision systems equipment (Nikon or Keyence) preferred.