Quality Engineer PM Consultant

Description:

ACTUAL JOB TITLE - QUALITY ENGINEER II

Position is remote and can be homebased anywhere in the US

Are you an innovative 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?

What You Will Do:

As a Quality Engineer II, you will have the opportunity to provide engineering support 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 non-conforming events and product failures 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:

• Must be able to interface well with others, especially Manufacturing Engineering.

• Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices.

• Develop, implement and monitor quality metrics. Communicate status and progress.

• Develops systems for monitoring manufacturing quality. Recommends and assists, 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.

• Lead and support Health Hazard Analysis (HHAs) to ensure risk assessment and root cause analysis are consistent across products and systems.

• Develop 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

• Participate in the development and results analysis of validation plans (IQ/OQ/PQ) and test protocols to qualify and validate existing and new product designs and processes. Includes the use of various statistical techniques and quality tools.

• Support computer system validations for manufacturing and test equipment.

• Lead and support test method validations plans/protocols and reports.

• Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.

• Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.

• Lead the non-conforming material process and participate in or lead the Materials Review Board

• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.

• Experienced in basic inspection and testing techniques; must be able to read and interpret blueprints.

• Experienced in Medical Device Design control process is preferred.

Material and Equipment Directly Used:

• General measuring equipment such as calipers, micrometers, and tensile test equipment.

• Computers

• Applicable Production Equipment

• Applicable Software Packages

• Appropriate tools, as necessary.

Education/Experience Necessary:

• Typical experience required is a minimum of 3 years as an Engineer in the related field

• BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred.

• Solid experience in Risk Management for medical devices ISO 14971desired

• Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action

• Regulated industry preferred

• Statistical analysis (Minitab), JMP software preferred

• Proficient in the use of various measuring tools and troubleshooting equipment