Senior Quality Control Technician

January 29th, 2019


 

HLT, Inc. is a clinical-trial stage company founded in Minnesota in 2002. We manufacture a transcatheter heart valve system, consisting of a catheter-based delivery system and heart valve, to treat aortic valve disease.  The procedure is performed by an interventional cardiologist / cardiac surgeon in a cardiac catheterization laboratory, and is expected to be both less invasive and less costly than an open heart valve replacement procedure.  The company currently employs approximately 100 people in Maple Grove, Minnesota.

In 2010 HLT was acquired by The Bracco Group, an international company active in the healthcare sector through Bracco Imaging. The group employs more than 3,300 employees worldwide and has annual total consolidated revenues of more than $1 billion.

HLT seeks passionate and talented people who can start contributing from day one. We want innovators seeking to advance the state of the art to improve patient outcomes.

Position Summary:

The primary responsibilities of this position are to support inspection and equipment systems associated with the manufacture of the HLT transcatheter heart valves and delivery systems.  The role will participate in product and process improvement projects to drive continual improvement of product quality.   The position will provide administrative support to key quality systems processes such as: equipment qualification/maintenance, non-conforming material control/review, training, data analysis and trending.

Primary Duties and Responsibilities:

Support Manufacturing and R&D in valve product and process improvements, including analysis and trending of quality data:

  • Work with Manufacturing and R&D to implement product, process, and inspection method improvements within the Quality Management System (QMS) requirements
  • Develop metrics to highlight areas for improvement as well as demonstrate effectiveness of implemented improvements and corrections

Provide Support to the administration of calibration, preventative maintenance, and equipment qualification systems:

  • Registration and maintenance of equipment within the equipment tracking system
  • Evaluate requirements for new equipment, fixtures, and tooling
  • Support administration of calibration system
  • Schedule calibrations with service suppliers
  • Assess calibration results for conformance to requirements
  • Assess potential impact of out of tolerance equipment
  • Support the generation and analysis of calibration metrics
  • Complete inspections of new tooling and fixtures
  • Create and execute new equipment installation and qualification plans

Non-conforming material and MRB (Material Review Board) process:

  • Generate non-conforming material reports
  • Participate as a member of MRB on an as needed basis
  • Investigate root causes of non-conformances
  • Implement Corrections and Corrective Actions (CAPA)
  • Record and implement MRB decisions and actions
  • Support the generation and analysis of non-conformance metrics

Support incoming material and in-process inspection activities:

  • Direct inspection of incoming materials and in-process sub-assemblies
  • Prioritize and coordinate activities with QC Inspectors and production personnel
  • Drive continuous improvement in yields through targeted inspections

Final inspection and release of finished product:

  • Microscopic visual inspection of finished product
  • Functional proof testing of valve and interpretation of results
  • Review of device history records
  • Final release of product

Provide training and guidance to inspectors, technicians, and manufacturing operators:

  • Train and certify inspectors and technicians relative to methods, documents and use of specialized equipment

Qualifications (Knowledge, Skills & Abilities):

Minimum:

  • 2 year technical degree or 2 years of direct applicable experience will substitute for degree
  • 5-8 years’ of technician experience
  • Experience creating inspection methods for vision system coordinate measuring machines
  • Experience creating inspection or test methods for mechanical test systems
  • Excellent written and verbal communication skills
  • Ability to function in both a highly technical engineering team and with production level personnel, including facilitating communications between the groups
  • Experience creating and reviewing document change requests
  • Detail oriented approach to highly technical tasks
  • Ability to work with minimal direct supervision

Preferred:

  • 4 year technical degree or 4 years of direct applicable experience will substitute for degree
  • 5-8 years’ experience in a medical device company
  • Experience with MicroVu vision systems and MTS/Instron mechanical test systems
  • Experience or education in chemistry, mechanical engineering or related fields
  • Experience in Medical device industry, cleanroom and aseptic processing experience
  • Excellent manual dexterity and ability to work under a microscope

For further information about the position, please click here https://bit.ly/2ScoGbS