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Quality Engineer
Skills Required :
- Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.
- Actively participates in internal audits, management review and other activities covered under Lake Region Medical’s Quality Manual, Policies and Procedures
- Provide customer related quality and regulatory inquiries support
- Compiles and writes training material and conducts training sessions on quality control activities
- Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner. Directs development and maintenance of internal/external standards relative to Design and Development,
- Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE and process validation.
- Lead and provide Project Management support as needed
- Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
- Performs measurement system analyses to evaluate test and inspection equipment
- Leads disposition of discrepant material and devises process to assess product quality and reliability
- Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration
- Lead supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA
- Direct support for FDA and ISO inspections and registration
- All other duties as assigned
- Support and Participate in Continuous Improvement activities
- Support and Participate in activities that increase the ratio of value added to non-value added processes
- Demonstrates leadership through mentoring of junior staff and responsiveness to business needs to achieve positive results
- Demonstrates technical ability through the application of engineering skills, approaches and knowledge
Qualifications
- Experience with FDA and ISO 13485 Certification inspections is a plus.
- Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred)
- Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include, but are not limited to Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus
- Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision
- Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills
- Bachelors in Biotechnology or Biomedical Engineering