This quality engineer position supports manufacturing to ensure delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives. This position interacts closely with the Operations team as well as Engineering, Quality Systems, Design Assurance and Regulatory. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Areas of support include incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- Perform other related duties and responsibilities, as assigned.
- Bachelor of Science in engineering, science, or technical field
- 2+ years’ experience in Engineering and/or Quality.
- Must be able to work independently under limited supervision.
- Knowledge of basic Quality Systems and good documentation practices.
- Experience in Non-Conforming Material Reporting
- Experience in investigating and implementing Corrective and Preventive Actions
- Experience in test method and process validation
- Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485.
- Advanced computer skills, including statistical/data analysis and protocol/report writing.
- Strong communication skills, both verbal and written.
- Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.
- Light work, exerting up to 20 lbs. of force or less.
- Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
- Requires typing, talking and hearing.
To apply, please submit your resume and cover letter as one document below.
|Position Reports to:||Quality Manager|