Quality Manager

Purpose: This position is responsible to assist the Vice President, R/A Q/A in the continuing development, maintenance, and improvement of the Quality Assurance and Regulatory Compliance policies and procedures within the company. This person will assist in assuring corporate compliance to all regulatory agency requirements in the engineering and production of our company's products and services.
PRINCIPLE ACCOUNTABILITIES:
1.Responsible for building and maintaining the total quality system (including QSR and ISO 9001/ ISO 13485 by planning, directing and implementing QA polices, procedures, and standards and controls throughout the organization to comply with United States and international requirements.
2.Responsible for executing compliance with appropriate regulatory standards for quality assurance including sterilization and bio compatibility/bio burden standards, materials inspection, calibration, and others as required.
3.Assure development and maintenance of adequate engineering, manufacturing, and materials control quality systems and policies. These requirements directly relate to the product development and implementation processes, documentation control, materials, vendor management/certification, parts and tooling inspection and control, product and labeling specifications, CAPA, and other regulatory requirements.
4.Perform analyses, as required, in conjunction with and support of engineering and manufacturing to define and/or optimize our design verification and manufacturing processes. Examples include risk (hazard) analyses, FMEA/FEA analyses, process control/capability studies, statistical performance metrics, etc.
5.Assist in coordination of company quality training and quality system management reviews and lead efforts to identify quality problems and to assure management focus to resolve issues quickly and effectively.

REQUIRED SKILLS:

-5-10 years experience in a significant quality assurance role in the medical device industry; minimum of a Bachelor's degree (technical/science preferred).
-Requires experience in quality requirements for U.S. and international markets (including EU, ISO ISO 9001/13485), QSR).
-Requires experience with sterilization and bio compatibility testing validation and handling of sterile product and related regulations.
-Requires experience in establishment of inspection criteria and methods for incoming parts, in-process and final assemblies.
-Requires ability to perform reliability and design analyses including risk analyses and FMEA's. Quality Engineering or related certification is desirable.

Please send resumes to jgranaha@aerotek for more information.Classification:Full-TimeCompensation:
DOE YearJoin Aerotek CESM, one of the leading providers of engineering and engineering support professionals in North America. 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 a number of different industries. 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 CE 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 CE team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
QUALITY ASSURANCE, ISO, Bachelor''s Degree, QSRContact Information
Contact:Granahan,Julie M