How You'll Create Impact
Essential Responsibilities and Duties
Participate on project teams as a contributing member by providing quality engineering support under the direction of Sr. Design Quality Engineers & management in the development of new products and processes, supporting legacy released systems, and continuously improving company’s products.
Provide support for the manufacturing areas (internal and external). Work with production personnel and supervision to determine and monitor quality metrics, sample plans, and inspection methods.
Participate in the non-conforming product process to address and resolve issues. Support corrective and preventive action investigations to resolve the root cause of problems.
Perform inspections and use typical equipment used in inspection.
Assist project teams on compliance with design control requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO/EN standards
Participate in risk management activities in compliance with ISO 14971 as expressed in the company’s Quality Management System.
Assist in supplier qualification process; interface with suppliers to ensure product compliance to specification.
Support the execution of verification & validation protocols, testing, and generation of test reports.
Assist in Design Control and Transfer for release of new product development projects.
Support the writing and reviewing of procedures, plans, protocols, and reports to ensure regulatory compliance.
Accurately represent quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.)
Other duties as assigned
Your Background
Bachelor’s in engineering or technical discipline
Familiarity with 21 CFR 820 and ISO 13485:2016 and other Government / ISO Standards
Familiarity with Medical Device Design Controls preferred
Technical writing skills that include Quality Management Systems (QMS) and procedures
Knowledge in Geometric Dimensioning and Tolerancing (GD&T)
Knowledge in Machining methodologies preferrable (Titanium and Stainless-Steel experience best), knowledge of hardness, passivation, surface treatments, cleaning techniques etc. for communication with Suppliers and Engineers.
Competent computer skills (MS Office Suite, SAP Preferred)
Travel Expectations
Less than 10% overnight travel.
Compensation Data
Salary Range: $50,000 - $70,000 USD Annually depending on skills and experience
EOE
