Quality Assurance Engineer Jobs in USA, NY, Skaneateles Falls | Rose International Job

Rose International

Skaneateles Falls, NY

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JOB DETAILS

SALARY

$28–$32 Per Hour

JOB TYPE

Temporary

SKILLS

American National Standards Institute (ANSI), Analysis Skills, Blueprints, CAD (Computer-Aided Design) Software, Code of Federal Regulations, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Analysis, FDA (Food and Drug Administration), Functional Configuration Audit (FCA), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Investigative Reports, Manufacturing, Medical Equipment, Microsoft Access Database, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Minitab, Multitasking, Performance Management, Performance Metrics, Problem Solving Skills, Process Control Engineering, Product Marketing, Quality Assurance, Quality Engineering, Quality Management, Research Skills, Risk, Root Cause Analysis, Statistics Software, Strategic Planning, Support Documentation, Technical Drawing, Trend Analysis

LOCATION

Skaneateles Falls, NY

POSTED

6 days ago

Education Requirements:- Bachelor's degree in EngineeringRequired Skills for the Engineer - Quality Complaint Investigation:- 1-3 years of Medical Device experience- Investigational research skills- Experience with any statistical software packages - Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements- Knowledge and working application of reading and understanding blueprints and technical drawings- Demonstrated strong analytical problem solving - Root Cause Investigations- Display a solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools)- Computer competency in Word, Excel, Power Point, Minitab, Access and databases- Ability to multi-task and methodically manage projectsPreferred Skills:- Medical Device knowledge of 21CFR820 preferred- Minitab statistical package- Experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods- CMDASEngineer - Quality Complaint Investigation Overview:This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.Responsibilities:- Review individual complaints and associated service data to determine risk level and complete investigation into the “as “determined” problem code and cause codes for each complaint- Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues; Prepare and issue reports based on information analysis- Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner- Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products- Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions- Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation- Support CAPA and maintenance activities for existing product lines- Recommend and/or support projects for improvements to the quality system as approved by management **Only those lawfully authorized to work in the designated country associated with the position will be considered.** **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.** Benefits: For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website. California Pay Equity: For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here. 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. If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department. 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.).

About the Company

Rose International

Founded in 1993 by Sue Bhatia, Rose International is one of the nation's leading minority- and woman-owned providers of Staffing and Total Talent Solutions. We serve companies in all 50 states and employ thousands of people across the country.

COMPANY SIZE

2,500 to 4,999 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

https://www.roseint.com/