Quality Engineer

Company: Advantage Technical Resourcing
Location: Morrisville
Posted on: February 22, 2021

Job Description:

TQ experience and ISO certification (preferred not required)

Hiring manager requires resource to have a Science degree at the undergraduate level (minimum). Ideal candidate has a pharmaceutical background in Quality Assurance. Has worked on Investigations. internal audits, and change controls for documents and processes. Can work in a fast paced warehouse/office environment.

Job Information

Job Taxonomy: US07927 - Quality Engineer (US)

Job Title: US07927 - Quality Engineer (US)

Job Description: The Quality Assurance Engineer is responsible for oversight of all Quality continuous improvements. Uses Quality Engineering principles, tools and techniques to develop and optimize systems and processes so that they are aligned with the overall Company strategy and mission effecting continuous quality improvement. Coordinates or performs testing to verify equipment and processes comply with all AMRESCO specifications, applicable FDA regulation, and ISO requirements. Develops associated documentation. Leads process improvement projects and provides technical input and assistance. Performs system reviews and drives system improvements for both quality and efficiency using Corrective Action/Preventive Action (CAPA) processes. Leads continuous improvement and support maintenance of ISO and other regulatory certifications. MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance) * Provide guidance to management staff on the integration of FDA regulations and ISO standards into the Quality Management System (QMS). * Evaluate and advise management on current regulations and standards, new regulations and/or standards and proposed changes. * In conjunction with Managers and Supervisors, provide technical support in regards to the revision or implementation of QMS documentation including procedures, work instructions, and forms. * Support, consult, train and lead quality improvement projects for AMRESCO Inc products and processes by: * Providing technical support and input on validation protocols and processes * Participating in the improvement of production and service processes. * Utilizing quality tools and techniques to analyze processes and suggest improvements * Conducting and participating in FMEA activities * Participating in the planning and design of processes * Maximizing efficiency and quality by analyzing layout of equipment, workflow, assembly methods and work force utilization * Participate in the development of QMS software system. * Use Six Sigma methodology to drive quality systems improvements. * Assist in Six-Sigma and Lean Manufacturing initiatives in operations and other parts of the organization. * Manage internal audit program and serve as lead auditor. * Perform system, product and process audits, including audit follow-up and closure. * Recommend changes to internal systems and processes based on audit results. Advise and assist in development and implementation of new procedures and processes as a result of audits. * Manage Corrective and Preventive Action program. * Performs other duties as assigned.

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions) Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level. Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on routine basis. Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 50 lbs While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually moderate.

Skills/Experience: QUALIFICATIONS (Education/Training, Experience and Certifications) * Bachelors degree in Engineering or similar scientific or quality discipline; * 3-5 years applicable experience * American Society of Quality (ASQ), Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) and Six Sigma training desired.

KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently) * Working knowledge of the applicable FDA regulations as well as ISO 9001 and ISO 13485. * Working knowledge of quality tools and techniques such as SPC, FMEA, DOE, ANOVA, Root Cause Analysis, Pareto Charting, Cause and Effect Analysis, PDCA etc. * Strong Computer skills * Strong communication, presentation and team skills * Strong organizational and time management skills * Strong oral and written communication skills * Self motivated with a high level of initiative * Strong data analysis and reporting skills * Knowledge of Quality System, FDA, ISO regulations, CAPA system, GMP practices.

At Advantage Resourcing, our primary objective is to perfectly align the best people with the appropriate jobs. These jobs may be temporary assignments or career positions. We place talented people in a wide variety of jobs working with our client companies in areas such as: engineering, IT, technical, manufacturing, skilled trades, distribution, call centers, clerical, accounting, finance and sales.Our strength is being able to solve our client's workforce needs by matching people that have the right skills, knowledge and motivation to each opportunity. Advantage Resourcing can help you discover the personal and career success you desire.Advantage Resourcing Americas, Inc. is an Equal Opportunity Employer offering employment without regard for race, color, religious creed, national origin, ancestry, gender, marital status, age, sexual orientation, sex, gender identity, disability, veteran status, or other legally protected categories. Advantage Resourcing is a VEVRAA Federal Contractor. - provided by Dice

Keywords: Advantage Technical Resourcing, Cary , Quality Engineer, Accounting, Auditing , Morrisville, North Carolina