This role will be focused on ensuring company compliance to product-related specifications and procedures by maintaining and improving upon existing quality programs. The technical expertise of the Qualty Engineer will be utilized in programs such as Supplier Qualification, Product Inspection, CAPA, Validation, Nonconforming Material Management, Management Review and aiding R&D and Manufacturing with product complaints and investigations.
- Provide support for procedural changes identified as part of ISO 13485:2016 updates.
- Oversee the evaluation, action plan development and root cause analysis completion of CAPA activities.
- Apply root cause analysis and systematic problem-solving methods in identifying, prioritizing, communicating, and resolving quality related issues.
- Write and review quality documentation such as procedures, test protocols and reports.
- Coordinate efforts with department leads for the development and implementation of new and updated Quality System procedures and processes.
- Work with department leads in identifying and establishing quality related metrics.
- Assist in the investigation and processing of product investigations for nonconforming materials (NCMRs), and product returns/complaints
- Assist in the development and optimization of current quality processes such as RMA, Supplier Qualification, Audits and Nonconformance’s.
- Assist in the development of process monitoring and measurement tools.
- Assist in the creation of statistical techniques for metric generation methods.
- Assist in the development of risk based assessments to determine inspection requirements and acceptance criteria.
- Provide support with Internal & External audit activities.
- Provide support with IQ, OQ, PQ and Validations to support ISO 13485:2016 requirements.
- Bachelors of Engineering (Biomedical, Industrial, Mechanical) or Science degree required
- QE ASQ Certification highly preferred
- Quality experience within the medical industry with a minimum of 3 years in FDA/MDD regulated environment (Startup company experience preferred)
- Class III Device, Sterilization Validation, and Software Validation experience preferred
- Demonstrated experience/results in Quality System tools and problem solving
- Strong knowledge of ISO 13485 and QSR/cGMP requirements
- High-mechanical aptitude and knowledge of device manufacturing methods (e.g. injection molding, extrusion, machining) are strongly preferred
- Knowledge of applied statistics (sampling plans, regression, Cpk, confidence/reliability analysis) preferred