We are currently seeking candidates for a Quality Engineer position. Duties include the following:
Qualified candidates will have the following:
- Provides support to ensure company compliance with FDA Quality System Regulations and ISO 9001:2008 and ISO 13485 standards.
- Actively participates in internal audits, management review and other activities covered under the Cadence Quality Manual, Policies and Procedures.
- Provides customer related quality and regulatory inquiries support.
- Actively participates in the development of the Manufacturing Supply Base including surveillance audits and Corrective Action closure.
- Compiles and writes training material and conducts training sessions on quality control activities.
- Provides quality engineering direction, analysis and recommendations for product development to successfully launch new products into active production in a timely and cost effective manner.
- 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.
- Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration.
- Monitors and directs quality group on certificate of compliance requirements and improvement or implementation of systems to support certificate creation.
- Assists workers engaged in measuring, testing, and tabulating data concerning quality and reliability.
- Leads or participates in the implementation of continuous improvement projects or acts as subject matter expert for SPC, FMEA, DOE and process validation.
- Provides Project Management support as needed.
Cadence, Inc. offers a comprehensive benefits package, including health insurance, dental insurance, disability, 401(k) plan, and an incentive plan. If you are interested in applying for this position, please click "Apply for this job" at the bottom of the webpage.
- Bachelor’s Degree in Engineering or Quality related field desired. At least 2-3 years experience in the Medical Device or other highly regulated industry is preferred.
- Experience with FDA, ISO 9001:2008, and ISO 13485 is 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.
APPLICATION TIP: Candidates will be screened based on how well they meet the criteria defined above, as well as their responses to the questions required to be answered as part of the application. Candidates are encouraged to provide specific/detailed information regarding their experience and skill set on their application and/or resume.
Internal candidates with at least 6 months of experience in their current position/on their current shift will be given preference for a lateral transfer over candidates with less than 6 months of experience as detailed in the Recruitment Policy (page 21 in Employee Handbook).
Cadence, Inc. is an Equal Opportunity and Affirmative Action Employer. M/F/D/V.
Cadence, Inc. - 19 months ago