Director of Quality Engineering
Spectranetics - Colorado Springs, CO

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Are you an innovative Senior Level Quality Assurance Leader with a passion for the Medical Device industry? Do you thrive in directing product quality improvements, performance and compliance exciting? Do you enjoy managing change initiatives, and establishing systems to support a team?

If your answer is yes, Then we may be looking for you!

Spectranetics, recently named one of Forbes Magazine’s “Most Trusted Companies”,

has an opening for Head of National Sales for our Lead Management division.

What You Will Do: You will serve as the strategic leader on all objectives related to directing and overseeing quality assurance engineering. You will be afforded the opportunity to use your expertise to Develop, implement and manage systems and methods for identifying, monitoring and preventing internal and external product failures and their associated costs. Provide a variety of quality engineering services to all other company functions which ensure compliance with regulatory agencies. Manage and direct QE team.

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 and leaders in the Medical Device Industry who will support your continued growth. You will learn from our Engineers, Clinicians, Sales Leaders, and other industry professionals about our state of the art products.

What You Will Become: A highly influential leader who will be key in shaping strategy and driving execution for high impact results helping drive our mission of delivering consistently high quality, safe and effective, regulatory compliant products and services.

What Success Looks Like: You will have the opportunity to provide career growing results by:
  • Develop, implement and manage systems for monitoring product performance. Identifies and reports performance trends using sound statistical methods with leadership, integrity and vision.

  • Develop, implement and manage QE supported CAPA programs to ensure product quality.

  • Develop test methods and perform failure investigations in order to determine the root cause of failures on assigned projects.
  • Coordinate corrective action efforts with other groups (such as Manufacturing Engineering) to ensure teamwork and an integrated efforts to achieve objectives.

  • Participates in product development functions by recommending and implementing quality engineering plans and documentation that ensure quality objectives are achieved.

  • Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.
  • Develop strategies and programs that qualify and ensure external vendors supply products that conform to company specifications and quality requirements.
  • Review and provide recommendations on test protocols, requests for design changes and requests for product deviations to ensure documentation, methodology and overall content comply with quality objectives and policies.
  • Ensures integrity of environmental monitoring, controls and release of product (microbiology).
  • Responsible for direction of QE support in Design Control/New Product Development teams.
  • Responsible for Validation Master Plans and validation protocols to support Manufacturing and business quality requirements.
  • Responsible for embedded Quality Engineers in both medical device consumables and capital systems environments.
  • Responsible for technical test and analysis functions including FTIR and SEM
  • Leadership of supplier quality processes
  • Unfailing commitment to the safety of Spectranetics’ customers and patients

Supervisory Duties:

Manages day-to-day and project work of QA engineers, Technicians and Inspectors. Develops, with VP input, strategic direction for the department. Functional departments and key areas of responsibility include: Microbiology, QE Validation, new-facility qualification, QE (laser), QE (catheter), QE Test and Analysis, Supplier Engineering and Supplier Quality and QE Design Control.

Material and Equipment Directly Used:
  • Spectranetics’ Policies and Procedures and Drawings

  • FDA, ISO, QSR, MDD Regulations

  • Personal Computers

  • Various electrical/mechanical measurement and trouble-shooting equipment

Education/Experience Necessary:
  • BS Engineering discipline

  • CQE Certification – ASQ desired

  • Ten years in medical device industry with a minimum of 4 years in a management capacity in Quality Engineering function

Spectranetics - 17 months ago - save job - block
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