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Employment Type:
Full time
Job Category:
Contract Quality Engineer
(This job is no longer available)
The Spectranetics Corporation | Colorado Springs, CO
Grad Date

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Job Description

Are you an innovative Temporary Quality Engineer with a passion for delivering best in class Medical Device products? Do you live for the opportunity to improve the performance and reliability of products that save lives? Do you have the proven ability to collaborate, inspire and work with business leaders and customers to improve the quality function to meet business goals?

Then Spectranetics may be looking for you! Recently named one of the "Most Trusted Companies", we have an opening for a Temporary Quality Engineer.

What You Will Do: As our Temporary Quality Engineer you will have the opportunity to provide engineering leadership on a daily basis by developing, establishing and maintaining quality engineering methodologies, systems, and practices which meet world class standards. Among other tasks you will investigate Corrective and Preventive Actions (CAPAs) to drive product/process improvements with the objective of compliance safety and high customer satisfaction.

What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a great team of dedicated experts in your field, developing and implementing technology improvements. We are dedicated to the development and growth of our Teammates.

What You Will Become: A highly influential teammate who can build and support a world class Quality Engineering function by providing intelligence, discipline, problem solving and collaborative skills that can improve designs and processes.

What Success Looks Like:

* Extensive experience in CAPA and other Quality Systems.
* Provide perspective and input regarding regulations and industry best practice in CAPA and other Quality Systems.
* Participate in CAPA team in the identification and prioritization of CAPAs requiring closure.
* Support CAPA Lead Investigators and teams in the root-cause analysis, planning, coordination, execution, and closure of identified CAPAs.
* Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification.
* Develop and implement updates to Quality System Standard Operating Procedures (SOPs), as well as complete remediation of legacy Quality Records, as required.
* Develop and implement stand-alone CAPA action plans and reports.
* Interface well with a team of other Quality, Manufacturing, and R&D Engineers.
* Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Experience with ISO 14971, Risk Management for medical devices.
* Develop, implement, and monitor quality metrics. Communicate status and progress.
* Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.

Supervisory Duties: None

Material and Equipment Directly Used:

* Computers
* Applicable Software Packages (MS Suite, Agile)

Education/Experience Necessary:

* Typical experience required is a minimum of 5 years as an Engineer in a related field, BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred.
* Solid experience in Risk Management for medical devices ISO 14971 desired
* Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action (CAPA)
* Regulated industry preferred
* Statistical analysis, JMP software preferred, 3D modeling, Solidworks

Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.

This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.

All applicants must pass a pre-employment drug screen to be hired.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability.

About The Spectranetics Corporation

The Spectranetics Corporation (Spectranetics) develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system for use with Spectranetics' excimer laser system. The Company's laser system includes the CVX-300 laser unit and various disposable fiber-optic laser catheters. Its laser catheters contain up to 250 small diameter, flexible optical fibers that can access difficult to reach peripheral and coronary anatomy and produce evenly distributed laser energy at the tip of the catheter for uniform ablation. The Company's products are focused on two categories: vascular intervention and cardiac lead removal. As of December 31, 2008, the Company's installed base of laser systems was 850, of which 627were in the United States. On May 30, 2008, Spectranetics acquired the endovascular business of Kensey Nash Corporation (KNC). (Source: 10-K)