Search Jobs: Results: **HOT JOB** Senior Quality Engineer - New Product Development - Drug Delivery Medical Device
Multiple Design control quality engineer opportunities have been created to keep pace with active product launches in multiple divisions of this medical device leader known for focus on their employees professional development.
The Challenges:
1) Partner with R&D, Manufacturing, Engineering and Regulatory experts to design and launch new large volume Class II products.
2) You will focus on process capability issues, customer issues and Quality Systems implementations and, from your findings, define and implement CAPA’s so as to lead operational improvements.
3) Now while you further grow your design control, design history and design review skills you will perform statistical and risk analysis, process validations and develop sample plans
Salary: Base will be dependent on your expertise and likely should be in the in the 80’s to approx 90k and will include excellent benefits, incentive compensation and stability.
Location: New Jersey
Contact: Apply below and/or contact Ira Mann at iram@fpccareers.com
Qualifications:
While a BS degree (Engineering preferred) and 4+ years of Medical Device Quality experience is required, MOST IMPORTANT is to document your experience with:
1) Design controls (and/or design reviews and/or design history file management) in a product development environment
Experience with the following also preferred:
- Quality Systems Implementations
- Opening and closing CAPA’s
- Drug Delivery or injector devices
- Process validation, design validation and test method validation.
- Statistical analysis, process development and sample plan development
- Product and process improvements
- Risk Analysis, Risk Management and FMEA
- Certification as a Six Sigma Green Belt or Black Belt desired
- Team leadership and project management skills
Key Words: design control, quality systems implementation, design review, design history file, drug delivery, FMEA, dFMEA, CAPA, SPC, statistics, process validation, injector, syringe, design validation, product development, Six Sigma, reliability, sample plan development
Job Details
| Name: | Ira Mann | Date Posted: | 7/28/2010 |
| Office: | Atlanta | Telephone: | (770) 246-9757 |
| Email: | iram@fpccareers.com | Fax: | |
| Category: | Medical Device, Product Development, Quality Assurance, Quality Engineer | ||
| Keywords: | design control, quality systems implementation, design review, design history file, drug delivery, FMEA, dFMEA, CAPA, SPC, statistics, process validation, injector, syringe, design validation, product development, Six Sigma, reliability, sample plan development | Region: | |
| State: | NJ | City: | |
| Education: | BS | Job Number: | J55501-ATLA-15252-IM |
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