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| Quality / Reliability Engineering: |
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| Location: |
Hammond, IN/East Chicago, IL area |
| Title: |
Quality Engineer |
| Description: |
Quality Engineer needed with Medical Device industry, Validation and Production experience. Job Duties Include:
- Transition the product from the development phase to the production phase
- Plans and directs activities concerned with development, application, and maintenance of quality standards for industrial processes, materials and products by performing the following duties as applicable to new product development in medical field
- Develop/implement and Supplier Audit Programs
- Develop/initiate methods for inspection, testing, and evaluation
- Devise sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
- Establishes methods to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities
- May also be training quality inspectors
This is a long term contract assignment.
REQUIREMENTS
- 7-10+ years of recent and relevant experience
- Medical Device experience required
- Quality validation experience (IQ/OQ/PQ) and statistical analysis to validate manufacturing processes and new product development processes from the quality side (not a manufacturing validation engineer)
- Ability to work independently and manage multiple issues at once
- Should have experience with FDA audits & regulations, GMP, production controls, developing in-process checks and documentation
- Experience with extrusion, molding and assembly processes in compliance with FDA CFR 820 would be a plus
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| Application Submission: |
Email resume as a word attachment to: resume@ariesgroupinc.com
Reference Job Code QEIN90 |
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| Location: |
Foxboro-Taunton, MA area |
| Title: |
Quality Engineer |
| Description: |
Quality Engineer needed to establish and maintain a corporate quality system and to provide quality assurance support to medical device development and validation efforts. Other Job Duties Include:
- Various aspects of implementing and maintaining ISO 13485 and FDA GMP quality system procedures
- Participate in product development teams to provide design control quality assurance functions
- Participate in the technical review of design input specifications and design documentation for new medical devices
- Plan, develop and execute verification and validating testing for products under development
- Perform internal quality and design control audits
- Participate in medical product risk analysis
- Assist corporate management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements
This is a contract assignment expected to last 6-12 months; possibly temp to perm.
REQUIREMENTS
- 5-10 years of recent and relevant experience
- 4+ years in medical device quality assurance is a must
- Need to have design control experience as well as validation experience
- Experience with NCMRS (Non-Conforming Materials Reports) quality tracking system or similar complaint systems, along with CAPA (Corrective Action Preventive Action) corrective action regulatory compliance software
- A working understanding of FDA Quality System regulations, EU Active Implantable and Medical Device Directives, and ISO 13485 principles
- Knowledge of IEC 60601 medical device safety standards and IEEE software quality standards is preferred
- Requires a motivated individual that is able to work with minimal supervision
- B.S. Degree in Engineering required
- ASQC Certification desirable
- US Citizenship or Green Card preferred
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| Application Submission: |
Email resume as a word attachment to: resume@ariesgroupinc.com
Reference Job Code QEMA89 |
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| Location: |
Buffalo, NY area |
| Title: |
Reliability Engineer |
| Description: |
2 Reliability Engineers needed for a contract position in the Buffalo, NY area. Job Duties Include:
- Reliability, Maintainability and Product Support Functions
- Developing repair strategy and maintenance processes
- Participating in design projects to address reliability, maintainability and product support requirements
- Preparing product FMEAs
- Prepare certification documents to the FAA and EASA as well as develop product MTBF data and MTBUR data for maintenance documents and manuals
This is a contract assignment expected to last at least 9-12 months.
REQUIREMENTS
- Minimum of 3 to 5 years of recent and relevant experience in Reliability Engineering
- Must be American Society for Quality (ASQ), Certified Reliability Engineer
- BS in Reliability Engineering or Mechanical Engineering Preferred
- Familiarity with low volume/low cycle, static machines is a plus
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| Application Submission: |
Email resume as a word attachment to: resume@ariesgroupinc.com
Reference Job Code RENY29 |
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| Location: |
MA & MN- one contractor needed for each location |
| Title: |
Quality Engineer |
| Description: |
2 Quality Engineers needed (ideally, one will be based in MA & one in MN). Job Duties Include:
- Line transfer project, moving manufacturing/production lines from one facility to another
- Validate the Quality procedures, Quality Systems, QA and do all the heavy FDA documentation
- Transferring work instructions, assembly instructions & packaging instructions (packaging cleaning equipment)
- Performing quality assurance on the inspection methods for small machined parts
- Occasional travel involved
These are contract assignments expected to last 6-12 months.
- 5+ years relevant experience as a Quality Engineer
- Previous line transfer project experience is required
- Process Validation experience (IQ/OQ/PQ)
- Medical Device experience required, Dental experience a plus
- US Citizenship preferred
- Degree preferred
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| Application Submission: |
Email resume as a word attachment to: resume@ariesgroupinc.com
Reference Job Code QEMA27 |
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To be considered for these positions, please
e-mail your Word formatted resume to resume@ariesgroupinc.com
and reference the job title and location.
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