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Opelika, AL 36801
Client Position Title: Principal Quality Engineer
Position Number: 324716
Location: Opelika, AL 36801
Desired Skill Set:
Quality Engineer, CAPA, Validation
Position Description:C2C is not available
Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.
Job Title: Principal Quality Engineer
Contract Start: ASAP
Duration or End Date: 04/13/2020
Location: Opelika, AL 36801
The Principle Quality Engineer is intended to be a key position in the Quality organization with technical expertise to support the manufacturing operation and to support Quality Systems. This position will have an active role in providing technical expertise to support the plant’s Quality Systems, release of finished products, and to support the qualifications required to support the operation’s improvement projects.
Essential Duties and Responsibilities:
• Investigates customer complaints and identifies necessary corrective actions to improve product quality. Makes sure information is input into complaint handling software.
• Acts as coordinator for CAPA systems including nonconformities. Makes sure information is documented properly including input into Trackwise system. Responsible for trend analysis of CAPA and nonconformity events. May be required to take lead role in CAPA activities such as investigation, implementation, or verification of effectiveness. Follow up with CAPA owners to make sure CAPA activities are completed within schedule.
• Act as coordinator for Change control activities including performing Quality assessments. Responsible for trend analysis of Change Control events. Follow up with Change control owners to make sure activities are completed within schedule.
• Provides Quality Assurance support and guidance for validations including the testing and documentation for sterilization validation.
• Support dialyzer lot release for lots with exceptions or as back up to laboratory lead. Involves review and approval of lot history records.
• Maintains technical documentation including Technical Files and Risk Management documentation.
• Participates in internal audit program as lead auditor.
• Works with purchasing to provide feedback of quality performance to suppliers
• Assists with facilitating external audits
• Acts as deputy to the site Quality Manager during absence from facility.
• Qualified Lead Auditor strongly preferred
• Strong attention to detail required
• Ability to influence management on courses of action with minimal assistance though written and verbal communication
• B.S. in Engineering and 5 – 8 years related experience.
• Experience in an FDA or other government-regulated operation strongly preferred.
• Knowledge of MDR and vigilance reporting requirements preferred.
• Experience with CAPA, Change Control, and validation preferred.
• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Position requires standing and walking for extended periods of time.
• Requires standing, walking, lifting up to 25 lbs., bending, pulling, pushing, and climbing stairs.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)