The Quality Engineer will provide Quality Control and Manufacturing support to ensure all products meet our customer requirements. Develop process control and establish appropriate control system. Perform and document internal quality audits and make required recommendations. This role will report to the Quality Control Manager.
Excellent decision making and analytical skills
Excellent written and oral communications
Detail oriented with ability to pay attention to minute details for a project or task
Self- motivated with the ability to be internally inspired to perform a task to the best of one’s ability using his or her own drive or initiative
Motivated and quick learner able to work independently and as a team member
Develop and document work instructions for product inspection to ISO 9001/13485 requirement and Medical Device Regulations.
Ensure compliance to ANSI/ASQC Z1.4-1993 (sampling).
Lead and participate in Continuous Process Improvement and lean initiatives.
Review engineering changes (ECO) for QC and Implement requirements.
Perform Internal Audits of Processes and Procedures per schedule.
Organization and monitoring of all production tools and equipment for calibration or maintenance.
Leads investigation, containment and prevention of customer quality problems and manage completion of corrective actions requests to reduce Out of box defects and customer quality incident reports.
Provides Quality oversight and feedback to other departments as appropriate to preclude future recurrences of problems.
Validates and analyzes organizational customer quality metrics and performs periodic reviews to evaluate results and recommendation action plans to close gaps in the supply chain.
Other duties may be assigned.
Excellent PC skills in Windows, Excel, Word and Power Point.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Comprehensive knowledge of statistical tools, control plans, problem solving methods, i.e. 8D and the associated statistical tools used to analyze problems, evaluate and complete improvement projects.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Required – 4 Year College Degree or 3 years related experience and/or training; or equivalent combination of education and experience.
Preferred – ISO 9001/13485 training/ certificate of completion. 5S, Lean Manufacturing, Kaizen and SPC experience.
Previous Project Management experience preferred.
If you have a passion for excellence and want to work with an outstanding team of experts, working in an exciting, challenging, fast paced environment for the world’s leading assistive technology company, please send your resume to firstname.lastname@example.org.
Vispero actively seeks to develop greater levels of diversity in our workforce and in our pipeline of future employees. We are committed to attract and retain candidates who have a passion for their work and encourage all individuals to apply. Vispero is an Equal Opportunity Employer.