The role of the Quality Engineer (I) is to monitor, test and report on the quality of products and related processes, to ensure they meet quality metrics, as established in a medical device quality management system. This includes inspection of product and materials used, maintenance of testing and process equipment, review and control of supplier performance, and identifying the root of quality problems and recommendations for improvements.
The Quality Engineer (I) assists in the development and execution of quality system procedures and provides collected data and analysis into the quality review program. This includes the qualification of changes, conducting risk analysis and investigations, performing corrections and preventive maintenance, and participating in audits of suppliers and processes. These activities include responsibility for ensuring the control of documents and records.
Product Development & Operations
- Contributes to the development, implementation, qualification and execution of test plans for product and processes.
- Performs standard quality engineering reviews of design documentation for compliance with requirements, including supplier quality and internal inspection records.
- Assist in the maintenance of quality system documentation and ensure records are easily retrievable.
- Assist with the execution of the supplier evaluation process.
- Support the quality data review meetings and management review meetings.
- Support testing of product improvements and design changes.
Product Acceptance & Investigations
- Controls the analysis, design, qualification, training and integration of test methods to ensure the quality of products and their components during incoming, in- process, and final test/inspection.
- Coordinates the documentation review, inspection workflow, training, problem solving, and calibration for SonaCare Medical products, fixtures and test equipment.
- Tracks and reports data according to quality metrics.
- Advises on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality.
- Participates in the non-conformance reporting system, driving timely disposition and closure. Leads and/or participates in MRB meetings. Identifies non-conformance trends and develops/administers technical investigation and corrective action programs to resolve recurring quality problems.
- Participates in the assessment and handling of returned products, and review of complaints.
- Provides test, inspection, and technical support for components, subassemblies, assemblies, subsystems and systems as required to ensure manufacturing processes are compliant with established procedures.
Post market Surveillance
- Support the daily execution of feedback, complaint, nonconformance, investigation, corrective and preventive action, deviation, incoming inspection, first article inspection, test protocol and report review, internal audit, supplier review and audit.
- Audit internal processes as required to ensure they remain compliant with established standards, provide support to the organization during 3rd party audits of the quality system, and assist with supplier audits, as needed.
- Contributes to product safety, product quality, and customer satisfaction related decisions (providing data-based and risk-assessment-based input)
- Provides input and technical support for quality improvement plans.
All other duties, as assigned.
BS Degree in engineering and technology, preferably Mechanical or Electrical.
5 or more years of experience in the medical device, electronics or related industry; preferably with electro-mechanical devices.
Experience and knowledge of drawings/schematics, test equipment, tools and fixtures used for quality testing and production, required.
Medical Device Quality System knowledge, including 21 CFR art 820 (QSR) and ISO 13485, Class II Medical Device experience preferred.
Good communication skills – written and oral, required.
Experience in a manufacturing environment, and/or customer service environment, preferred.
Experience utilizing IPC Class III standards for soldering and inspection, preferred.
Experience participating in internal and external audits (e.g., FDA, Notified Body), preferred.
Strong organizational and time management skills, required.
Experience with CAPA, complaint investigation, field action processes, and risk management, preferred.
Hands-on testing skills (electrical and mechanical), required.
Experience in the servicing of computer-based products, preferred.
While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time, as well as lift heavy objects.
- Recognized as a technical leader within the company and engenders trust when working with suppliers, manufacturing, engineering and customer representatives.
- Capable of leading an Improvement or CAPA project or working with a supplier or engineering team to resolve product quality issues.
- Works effectively on cross-functional teams to establish appropriate processes pertaining to quality.
- Excellent written and oral communication skills.
- Ability to formulate responses to common inquiries or complaints from technicians, customers and regulatory agencies.
- Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations.