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Quality Engineer IN Open (J#26764)
Education: Bachelors Degree
Experience: 1 - 3 years

Helix Medical is making a world of difference... all around the world.
As a global leader in medical contract manufacturing we offer the following services for medical device, pharmaceutical and IVD clients worldwide: product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Helix Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Helix Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland, and China.

MedVenture Technology Corporation is currently recruiting for Manufacturing Associates. MedVenture manufactures minimally invasive, handheld and catheter-based devices out of our 93,000 square foot state-of-the-art facility, strategically and centrally located in Jeffersonville, Indiana. MedVentures culture is positive and team oriented. In our environment we like to have fun while helping others with our cutting edge medical devices. Our company is very driven to lead in the medical device industry to improve the quality of life of the patients we serve.

We are currently hiring for a Quality Engineer Manufacturing who is:
*Driven and focused on ensuring quality for all manufacturing cells in operations.
*Energetic and has a Make it Happen attitude to develop operators and technicians.
*Striving to ensure Quality procedures are in place, accurate and followed.
*Self-motivated and thrives in a fast paced, cutting-edge, lean systems environment, where priorities can often change on a daily basis.

Basic Responsibilities
*Ensure the manufacturing cell is aware of and meeting the customers quality needs and approval requirements. Provide clear product acceptance standards.
*Support the manufacturing cell to create, monitor and investigate the effectiveness of the product line quality plan to identify, bracket, correct, and prevent defects or issues related to productivity, downtime and equipment issues.
*Support continuous improvement efforts to improve productivity through lean principles including but not limited to line layout and balancing, WIP reduction, material flow and equipment downtime.
*Train in-process inspectors and provide them with clear inspection instructions and standards of work to drive improvements in the quality of the products. Ensure actual inspector activities are reflected in appropriate documentation.
*Support the Manufacturing Engineer in efforts to ensure equipment and line is validated, qualified, and calibrated.
*Coordinate product bioburden and LAL testing and ensure lot is properly released when MedVenture is responsible for product sterilization.
*Develop and maintain a relationship with the customers quality representative(s).
Improve Quality. Focus on product, process, and paperwork quality by incorporating the following activities:
oSupport and/or lead activities for identification of root causes of non conformances. If a CAPA is issued support the efforts to ensure the item is closed in an appropriate amount of time.
oSupport MedVenture Supplier Quality with supplier audit program and supplier changes.
oTrain personnel on incoming inspection methods.
oProvide support and expertise in DOE, reliability strategy, and analytical problem solving techniques.
oLead client audits for assigned projects and support internal audit programs as an auditor.
*Through early involvement in Product Development support efforts to smoothly and successfully transfer projects into a manufacturing cell by working with Product Development to clearly understand the receiving and in-process inspection requirements in order to train QA technicians.
*Assign work to technicians, less experienced engineers and temporary employees as needed including mentoring activities.
*Provide leadership and direction on project teams as it relates to the process development engineering functions.

Required Qualifications
*Bachelor of Science degree in Engineering
*Minimum of 2 years quality manufacturing work experience or equivalent (not entry level)
*Experienced in quality systems (ISO9000 and/or QSR)
*Behavior in line with MedVenture Values and Beliefs
*Proficient with reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, smart scope, multimeters, manometers, pull test and other inspection equipment.
*Demonstrated experience of leadership role in quality systems.
*Leadership ability and organizational skills
*Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
*Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc along with Minitab.
*Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
*Execute tasks in a timely manner without direct supervision.
Able to prioritize tasks.

Preferred Qualifications:
*CQE, CQA (ratings)
*Medical Device experience.

Its an exciting time to work at Helix Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Helix Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more at www.helixmedical.com/careers.

To Apply:
Candidates meeting these qualifications should complete the online application: https://freudenberg-jobs.dvinci.de/cgi-bin/appl/selfservice.pl?action=startapp;job_pub_nr=6B585942-F376-4662-918B-5D9AF3484FAA;p=homepage_com;job_pub_type=extern

Helix Medical is an Equal Employment Opportunity Employer.
 
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