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Principal / Lead Quality Engineer Pharma/Medical Device

Location: Opelika, Alabama 36801
Posted:Fri, September 20, 2019
Salary:Up to US$0.0 per hour
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Job Title: Principal / Lead Quality Engineer - Pharma/Medical Device
Location: Opelika Alabama, 36801
Job Duration: 6+ Months

To perform this job successfully, an individual must be able to perform each essential duty
List knowledge, skills, and/or abilities required.
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

Education and/or Experience. Include the education and/or experience that is necessary to perform the
job satisfactorily.
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.

Essential Duties and Responsibilities. This section contains a list of five to eight primary
responsibilities of the work. The incumbent will perform other duties as assigned.
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.

Experis is an Equal Opportunity Employer (EOE/AA)

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