Job Details

A Few Words About UsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Position: Validation Manager

Location: Hercules, CA

Duration: Full time

Job Description

Lead Engineering Verification and Validation Activities managing a small contingent of validation engineers.

Serve as Subject Matter Expert (SME) for all verification and validation activities

Develop and oversee verification protocols to verify engineering specifications

Develop and oversee validation protocols to validate customer requirements

Analyze verification and validation test data

Document test protocols and reports

Support Root Cause Analyses and Develop Corrective Measures

o Conduct root cause analysis using test data and/or field failure data

o Develop and verify/validate effective countermeasures against root cause(s) of failure

Support Reliability Improvement Projects

o Apply methodologies to drive reliability improvements

o Develop and execute reliability test methods

Required Skills

An understanding/working knowledge of Fluidics/Filling Operations, Automation, Robotics, Cold Storage, Packaging, and site validation. DI Water Systems

Highly proficient in the use of MS Office Suite (Word, Excel, Power-point, Project)

Proficient in the use of Minitab and/or other statistical analysis software

Excellent written and verbal communication skills

Ability to work effectively in teams cross-functionally and within engineering

Ability to multitask effectively and efficiently

Ability to work effectively with general direction

Highly capable of independent and critical thought and action

Required Experience

BS/MS in an Engineering discipline or Physical Sciences

Test Implementation, Verification & Validation, and Risk Assessment

Root Cause Analysis, Development of Corrective Actions

Hands on application of Statistical Analysis

Working knowledge of FDA regulatory requirements and all internal quality standards

5-7 years of experience in medical device validation/FDA regulated industry.

3-5 years of management leadership experience

Qualifications

BS/MS in an Engineering discipline or Physical Sciences