Quality Manager

Purpose: Development and maintenance of the Quality Management System in alignment with the BioMeasurement Division?s mission and in accordance with FDA Code of Federal Regulations, ISO 13485, Medical Device Directives (MDD) and other applicable regulatory requirements.

* Planning and facilitating quarterly and annual management reviews of the quality management system.

* Provides leadership in the improvement of quality system policies and procedures.

* Investigate system gaps and failures and work with business partners to ensure successful resolution

* Oversee customer complaint investigations and lead complaint review team

* Acts as Internal Lead Auditor having responsibility for developing audit schedules, audit plans, selecting, evaluating and training internal auditors, documenting non-conformance(s) and reporting nonconformance to management.

* Plans or conducts training for improvement techniques and facilitates quality system improvement activities. This includes control of quality system implementation, assistance and guidance in solving manufacturing and quality issues, and taking an active role in the development and implementation of improvements.

* Provides expertise along with subject matter experts in key areas such as Risk Management, including FMEA, Process Validation, and CAPA

Classification:
Direct Hire

Compensation:
75k OR DOE Year

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
Bachelors Degree in Engineering or Life Sciences, Project Management Skills, Medical Device Experience, 8+ Years Experience in Quality Systems, Medical Device Quality System Knowledge Including ISO 13485 & QSR, Demonstrated Skills in SPC, DOE, FMEA, Risk AnalysisContact Information
Contact:Oliha,Gabriel