Temporary Test Method Validation (TMV) Quality Engineer

[Ckuenstler]

Are you an innovative Quality Engineer with a passion for Test Method Validation and Measurement Uncertainty? 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 Quality Engineer.
What You Will Do: As our TMV-MSA Quality Engineer you will have the opportunity to provide engineering leadership on a daily basis by developing, establishing and maintaining metrology systems, methodologies, and practices which meet world class standards. Among these tasks you will support other teammates in guiding and development of cogent TMV plans, calculate and verify uncertainty analysis, develop and maintain process controls and proficiency testing. Additionally, you will support development, integration, and maintenance of our Calibration and Measurement Capability (CMC) uncertainty values for all quality laboratories and monitor performance through statistical methods and proficiency testing.
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 metrology function by providing intelligence, discipline, problem solving and collaborative skills that can improve designs and processes.
What Success Looks Like:
•   Lead continuing Test Method Validation and Measurement System Analysis efforts
•   Must be able to interface well with others, especially Production supervisions, Manufacturing Engineering and R&D Engineering
•   Must have excellent data entry, technical writing, statistical analysis and documentation skills
•   Must have familiarity wide variety of test equipment from CMM/Vision systems to simple handheld measurement tools.
•   Follow established validation strategies so that all appropriate requirements are being met from planning, protocol definition, leading execution of protocol, analyzing and reporting results and defining procedures and training requirements, completing report and gaining approval to close
•   Ensure methods meet the requirements of ISO/IEC 13485, ISO/IEC 17025, as well as other worldwide regulatory agencies
•   Determine and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.
•   Partner with engineering in selection of measurement equipment and fixture design ensuring appropriate accuracy and precision for processes to be measured
•   Develop, implement and monitor SPC on critical processes. Communicate status and progress
•   Develop systems for monitoring measurement system capability. Recommends and assist, as necessary, in the implementation of corrective/preventative actions
•   Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification
•   Guide with inspection and testing techniques; read and interpret blueprints


Education/Experience Necessary:
•   Typical experience required is a minimum of 5 years as an Engineer in a related field, BS in Statistics, Mathematics, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred.
•   Solid experience with Test Method Validation and Uncertainty Analysis
•   Experience with leading problem-solving, root cause analysis and conducting Corrective and Preventive Action processes
•   Regulated industry preferred
•   Statistical analysis, Minitab software preferred
•   Proficient in the use of various measuring tools and troubleshooting equipment
•   Strong mechanical aptitude
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.

Apply Here: http://www.click2apply.net/7scdj7gzp5mztqgx

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