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
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
- 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
- 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
- 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
- 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
- Responsible for direction of QE support in Design Control/New Product
- 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
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
- 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 - 18 months ago