Location : Upper Saddle River NJ US 07458
Job Type : Temp/Contract
Reference Code : 19954-BZ1
Compensation : open - 30-35/h
Start Date : 09/11/2019
Hours : Full Time
Required Years of Experience : 2
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Engineering
Job Description :
- Contract position for a Reliability Engineer to perform and document failure investigations for customer complaints leading to the identification of root cause and potential corrective/preventive actions.
- Ensure timely closure of complaints to comply with FDA requirements. Perform reliability analysis to identify and address negative trends.
- Improve product quality, reliability and customer satisfaction by investigating product field failures and conducting trend analysis.
- Ensure timely, accurate, and complete failure investigations and root cause analyses through the use of QA tools (Root cause analyses, 4-D, 5 Whys, etc.) and document findings in TrackWise.
- Organize/lead cross-functional teams to help identify problem issue and drive product improvement.
- Deploy good design and manufacturing practices knowledge to make recommendations to prevent future failures.
- Support the resolution of field issues and work with R&D, Advanced Quality Engineering, and Operations in Quality, Product Development and Manufacturing to resolve issues.
- Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action.
- Lead product family complaint reviews by presenting complaint trends and recommendations for corrective action and product improvement.
- Work with Advanced Quality Engineers to complete post-market health risk assessments.
Required Qualifications :
- Bachelors degree in engineering or related discipline.
- Minimum of 2 years experience as a Reliability Engineer, Quality Engineer or relevant role conducting failure investigations and/or performing failure analysis.
- Demonstrated applied knowledge of advanced reliability tools such as Failure Modes Effect Analysis (FMEA), reliability testing, statistical techniques
- Demonstrated ability to effectively work cross functionally with other departments including Research & Development, Regulatory Affairs, Sales, Marketing, and Operations.
- Demonstrated interpersonal and communication skills.
- Demonstrated ability to exhibit a positive, energetic approach to teamwork.
- Demonstrated ability to advocate for product excellence and quality.
- Knowledge of FDA and international medical device regulations/standards/directives applicable to spinal implants and instruments (ISO 13485, ISO 14971, 21CFR820, 93/42/CE, cGMPs) is desirable.
Contact: Bill Zukowsky