Description
Title: Quality Engineer, entry (non-IT)
Skills: Bachelor's degree in Engineering or technical related field, 3-5 years relevant experience in Quality. Knowledge of ISO 13485, 21 CFR Part 820 and/or Six Sigma Training preferred.
Location: Mentor, OH
Area code: 440
ZIP code: 44060
Tax term: CON_W2
Pay rate: 28.00
Length: 2.5 months
Position ID: ISG670
This posting is for INDEPENDENTS only - Recruiters & Staffing companies NEED NOT APPLY
This is a CONTRACT engagement (W2)
The project is scheduled to start November 17 and run through January, 2015.
JOB DESCRIPTION:
Are you ready to be part of an emerging business that will revolutionize healthcare for consumers and clinicians? Can you partner with key members of the organization to develop and improve the Quality Systems that will deliver healthcare technologies that people connect with? Do you have a desire to develop and improve systems that create sustainable results? Then this role is for you.
KEY RESPONSIBILITIES:
-
Drive improvements to the quality system that ensures its suitability, adequacy and effectiveness.
-
Provide operational support related to issue resolution, product quality/risk assessment and product disposition.
-
Lead implementation of quality system processes which may include but are not limited to complaint handling, document control, corrective and preventative action, non-conforming material and deviations.
-
Provide facility quality support and representation in new product development, scale up, design transfer, and facility validation activities.
-
Represent quality on core design change and new product development teams to ensure the design control process is being followed effectively and to create deliverables including batch records and control plans.
-
Provide support in customer, supplier and regulatory audits.
-
Generate and provide quality metrics for management review.
KNOWLEDGE, SKILLS, & ABILITIES:
-
Bachelor's degree in Engineering or technical related field.
-
3-5 years relevant experience in Quality.
-
Knowledge of ISO 13485 and 21 CFR Part 820 preferred.
-
Six Sigma Training is a plus.
-
Experience handling multiple responsibilities with minimal direction.
-
Strong written and verbal communication skills; strong presentation skills.
-
Able to effectively work with various functions and levels within the organization.
-
Up to 10% travel.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin or disability.