Interesting Class 3 medical device company offers an opportunity to be the lead technical and systems knowledgeable resource in all quality and reliability matters. Lead and participate in the planning, problem resolution, documentation, continuous improvement, and conformance verification of single use disposable devices, from procurement, manufacture, and testing to distribution.
- Work closely with all departments on quality system compliance and product performance.
- Perform failure analysis and propose, initiate and follow-up on internal corrective actions Perform Internal Quality Audits and follow-up, including validation protocols and test plans.
- Assist in vendor management, surveys, visits, and supplier corrective action.
- Review and approve documentation for completeness, accuracy, producibility, and compatibility with existing documentation. Participate in Change Control sign-off and approval.
- Collect, analyze, act on performance measurement indices.
- Participate in process and device validation and qualification.
- Participate in and document risk analyses.
- Disposition non-conforming material.
- Provide technical assistance and support to suppliers on mechanical verification procedures.
- Review and contribute to inspection / test / calibration procedures for equipment and product.
- BS or MS in Mechanical, Electrical, Chemical, Biomedical or Industrial Engineering; technical certifications or training such as ISO 13485 auditor, ASQ certified engineer are a plus.
- Minimum of six years of medical device Quality Engineering experience in an ISO 13485 quality system, MDD and GMP environment.
- Direct experience with some of the following: applied statistics, biocompatibity / sterilization validation / aseptic processing, terminal packaging, injection molding, age and transit testing.
- Experience in one or more of the following, CAPA, Complaint Handling, Non-conforming Material, Change Order / Configuration Management (DMR/DHR/DHR), Supplier Quality, Failure Analysis, Quality Audits, Process Validation, Calibration, Risk Management, Design Control.
- Effective and professional communication skills with internal and external stakeholders.
- The ability to read technical specifications and utilize measurement tools and equipment.
- Computer literacy is mandatory (MS Office, Visio, Minitab, etc.).