Description
Senior Quality EngineerThe Company develops, manufactures and markets a family of medical device products internationally.
Job Functions
- Supports the creation and implementation of a quality management system infrastructure.
- Supports device manufacturing.
- Supports design and development for a variety of medical device technologies. Maintains compliance within a regulated environment (e.g. FDA, MDD).
Job Responsibilities
- Develops and implements quality system documentation (operating procedures, work instructions, specifications, and so on)
- Participates in cross functional project teams to support new product development and quality improvements
- Performs Risk Assessments (e.g. FMEA, FTA, Risk Analysis)
- Develops and implements acceptance activities (tests, test equipment, sampling, and inspection)
- Installs, operates, troubleshoots and maintains test equipment
- Performs statistical analysis/hypothesis testing (e.g. ANOVA, Weibull, DOE)
- Implements and monitors Statistical Process Control (SPC)
- Develops, implements, and monitors processes and procedures for environmental controls
- Develops and executes IQ, OQ, PQ protocols and reports
- Develops and implements corrective actions and preventive actions
- Determines outcome of non-conforming materials and devices
- Conducts internal and external quality audits
Job Qualifications
- B.S: engineering, or a related field
- 5-7 years experience in quality process improvement experience with class II/III medical devices
- Experience with ISO 13485:2012, ISO 14971:2012, 21 CFR 820, SOR 98/282, and MDD 93/42
- Computer skills (MS Word, Excel, PowerPoint, etc…)
- Exceptional writing skills
- Extensive knowledge and experience in statistical analysis
- Good English skills (written and spoken)
- Strong teamwork skills
- Results oriented
Other Requirements
- American Society for Quality certifications (CQT, QAT, CQA, CQPA, CCT) preferred