Cadence, Inc is ranked among the top life science companies providing outsourced design and manufacturing solutions for surgical devices and scientific applications. Due to the company's growth we are looking for a Quality Engineer to join the team at our Cranston, RI facility. Some of the benefits to you:
What will you do as a Quality Engineer at Cadence?
- Great Place to Work! – In 2011, we were named one of the top ten “Best Companies to Work For” by Medical Device and Diagnostic Industry magazine. From our company culture to our benefits program, Cadence is an awesome place work.
- Career Growth – At Cadence we consider our employees to be our most valuable asset, and as such we are committed to providing you an environment where you will be appreciated, respected, and challenged.
- Make a Positive Impact – At Cadence “do the right thing” is more than just a corporate motto; it’s our guiding principle and way life. You can be proud of the fact that what you do every day will help save lives.
The Quality Engineer works with operations and product development teams to ensure compliance to the Quality Manual and other procedures from product concept through market introduction. This position assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. Other duties include:
What are we seeking in the ideal candidate?
- Providing support to ensure company compliance with FDA Quality System Regulations and ISO 9001:2008 and ISO 13485 standards.
- Actively participating in internal audits, management review and other activities covered under the Cadence Quality Manual, Policies and Procedures.
- Providing customer related quality and regulatory inquiries support.
- Actively participating in the development of the Manufacturing Supply Base including surveillance audits and Corrective Action closure.
- Compiling and writing training material and conducts training sessions on quality control activities.
- Providing quality engineering direction, analysis and recommendations for product development to successfully launch new products into active production in a timely and cost effective manner.
- Developing and initiating standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
- Devising sampling procedures; designing and developing forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Performing measurement system analyses to evaluate test and inspection equipment.
- Monitoring and directing engineering group on calibration requirements and implementation of systems to support equipment calibration.
- Assisting workers engaged in measuring, testing, and tabulating data concerning quality and reliability.
- Leading or participating in the implementation of continuous improvement projects or acts as subject matter expert for SPC, FMEA, DOE and process validation.
- Providing Project Management support as needed.
- Other duties as assigned.
We are seeking a QE with a go-getter personality who is passionate about the quality field. The ideal candidate will have a Bachelor’s Degree in Engineering or Quality related field with a minimum of 2 years of experience in the Medical Device or other highly regulated industry. In addition, we are seeking someone with:
- Experience with FDA, ISO 9001:2008, and ISO 13485 (a strong plus)
- Experience with regulatory requirements and ISO Certification inspections
- 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 technical data.
- Excellent verbal & written communication skills, which include but are not limited to presentation skills, organizational skills and management skills.
- Experience using computer software for the analysis of data, preferably Microsoft Excel and statistical software packages
- Quality Engineering Certification (CQE) or equivalent preferred
- Six Sigma, Lean Manufacturing, and/or other manufacturing related certifications a plus
Candidates should be able function in both office and manufacturing environments of a multi-location corporation. The majority of time will be spent in the office environment. Occasional travel may be required. Must be able to tolerate sitting and working with a computer for extended periods of time. Fine motor skills are utilized when typing and using various office machines. Requires clear verbal communication, hearing ability and clear vision or reasonable alternative. Must be able to safely and effectively move throughout our facility and interact with employees. Willingness to work additional hours during the week and/or weekend, if required.
Cadence, Inc. - 9 months ago