Employers

Quality Engineer

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Job ID:

25907

Location:

Cincinnati, OH 

Category:

Engineering
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Job Views:

1110

Zip Code:

45241

Employment Type:

Full time

Posted:

03.17.2015
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Job Description:

Position Title:           Quality Engineer
Department:           Quality Engineering


 
                                            
 
 
 
Summary (Scope of Job):
 
  • The Quality Engineer position leads the Quality Engineering activities related to the successful manufacture and development of Enable Injections products.
 
Major Responsibilities:
 
1. Develop and manage Quality System Policies, Procedures and Documentation.
2. Approval and assessment of external suppliers and their Quality Systems to assure they meet cGLP, cGMP and other Regulatory requirements.
3. Develop inspection methods, techniques, and procedures for measuring incoming materials and manufacturing processes. Develop Quality sampling plans by applying attribute, variable and sequential sampling methods.
4. Coordinate and Manage Calibration and Metrology activities.
5. Participate in Product development and Risk Management activities.
6. Coordinate Customer Complaint follow up activities including investigations, trending, CAPA’s and reporting.
7. Establish, implement, and monitor methods and measurements to ensure quality. Establish statistical confidence by identifying sample size and acceptance error.
8. Support suppliers with difficult manufacturing problems (e.g. yield and quality improvement).
 
Educational Requirements:         Bachelor’s Degree and/or education/experience equivalent.  Quality Engineer Certification (CQE) preferred.
 
 
Experience Requirements:           A minimum of five years of experience with a Bachelor’s Degree, or three years of experience with a Master’s Degree
 
 
Knowledge and Skills:                      Knowledgeable in implementing and managing Quality Assurance systems and procedures.  Familiar with medical device manufacturing systems and methods. Possess a good balance of technical expertise, analytical thinking and communication skills for resolving issues internal and external to the organization. Competent with word processing, spreadsheet and statistical analysis software packages (preferably Word, Excel and Minitab).
Company Info
Enable Injections
2863 East Sharon Road
Cincinnati, OH, United States

Phone: 513-223-7301
Web Site: www.enableinjections.com

Company Profile