Search Jobs: Results: Senior Quality Engineer (multiple) - Medical Device Product Development & Design Control
Multiple roles exist in the SouthEast, New England, SouthWest and Great Lakes regions. Please contact for addtional details.
Key words include: ISO 13485, QBD, design validation, voice of the customer, VoC, design control, Design History Files, DOE, SPC, product development, FMEA, Risk assessments, RCA, Six Sigma, continuous improvement, reliability, SAP, MiniTab, SAS, QSR
Responsibilities and Requirements include:
- Develop and implement strategic quality plans, master validation plans, validation protocols, inspection plans and quality compliance SOP's
- Develop, design and document design history files and design validations
- Design control and new product introduction process
- Process qualification and validation
- Good understanding & experience in advanced problem solving including statistical techniques or SPC
- Lead CAPA teams through root cause investigations to implementation and final verification
- Develop, implement and monitor quality metrics.
- Sound understanding of quality concepts, regulatory compliance requirements and tools including ISO 13485;2003, DESIGN CONTROLS and the FDA QSR
- 3+ Years specific engineering experience (medical device) as well as a BS degree and experience in application and leading problem-solving, root cause analysis and related Corrective and Preventive Actions (including verification)(CAPA)
- IQ/OQ/PQ validation requirements from planning, protocol definition, leading execution of protocol, analyzing and reporting results and defining procedures and training requirements, completing report and gaining approval to close
Contact info: Apply below and/or email iram@fpccareers.com Additonal opportunities can also be viewed fpccareers.com
Salary levels: 80's and 90's plus bonus and relocation and long term incentives
Job Details
| Name: | Ira Mann | Date Posted: | 3/01/2010 |
| Office: | Atlanta | Telephone: | (770) 246-9757 |
| Email: | iram@fpccareers.com | Fax: | |
| Category: | Biotechnology, Medical Device, Pharmaceutical, Process Engineer, Product Development, Quality Assurance, Quality Engineer, Research & Development, Six Sigma/Lean Implementation, Validation | ||
| Keywords: | design control, product development, six sigma, continuous improvement, clinical, 510k, supplier quality, lean, reliability, sterilization, microbiology | Region: | Great Lakes (IL, IN, MI, OH, WI)|New England (MA, ME, NH, RI, VT)|South East (FL, GA, NC, SC)|South West (AZ, NM, OK, TX) |
| State: | City: | ||
| Education: | BS | Job Number: | J98815-ATLA-15063-IM |
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