Back to Jobs
Validation Engineer

Location
CENTRAL MA. MA
Job Category
Engineering
Compensation
$90,000.00
Company Industry
Manufacturing and Production
Date Posted
07/20/2012
 Create Account & Apply Now  Log In & Apply Now Save this Job
Validation Engineer

Location
CENTRAL MA. MA
Job Category
Engineering
Compensation
$90,000.00
Company Industry
Manufacturing and Production
Date Posted
07/20/2012

Validation Engineer

Job Description



QUALITY ENGINEER IV...MEDICAL-PLASTICS up to 90K + Excellent benefits-DIRECT


Position Summary:

Develops and implements quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses. Ensures that performance and product quality conform to established company and customer requirements. Reviews, analyzes, and reports on quality discrepancies related to the assembly and molding process. Leads investigation of problems and develops dispositions, modifications, and corrective actions for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met. Has primary responsibility for planning and implementing the position's key responsibilities as they apply to new product introduction.



Education and/or Experience:

BS Degree or equivalent in an Engineering discipline. Requires 6 - 8 yrs experience as a Quality Engineer with injection molds and automation (preferably with medical devices).

Key Responsibilities:

Leads the development, modification, and maintenance of quality evaluation and control plans and protocols for processing materials into partially finished or finished products

Leads the design and analysis of inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine responsibility for, products or materials that do not meet required standards and specifications.

Assists with managing Part Files that define statistical analysis requirements and any associated control limits, as needed, for Predisys SPC

Audits quality systems for deficiency identification and correction

May specialize in the areas of design , incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality

Writes, reviews and approves process validations/qualifications in accordance with Nypro and customer requirements

Assists in the process of ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001 and ISO 13485), Nypro Advance Problem Solving methods, and that documentation is complete and compliant with requirements

Assists in the preparation of Drug Master Files (DMF) submissions and reports. DMFs are to be

Supports plant Quality System software validation as needed as well as all company safety and quality programs and initiatives

Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/ position

DIRECT HIRE- CONTACT DEB AT MARATHON STAFFING 978-422-1381 email in confidence to dkilgour@marathonstaffng.com
About Marathon

Marathon is one of the largest regional employers, supplying temporary, on-site, contract, contract to hire and direct hire employees to companies throughout the United States. We have over three decades of staffing experience and place over 15,000 team members annually. Our offices are located in Alabama, Arizona, California, Massachusetts, Nevada, Ohio, South Carolina and Texas.

Marathon exists to help people achieve.

MARATHON IS AN EQUAL OPPORTUNITY EMPLOYER

Contact Us
38 Main Street, 1st Floor, Leominster, MA 01453
Phone: 978-840-8887
Fax Number: 978-840-8886
For more information about this position, email Deborah S Kilgour

View other Jobs in: