Senior Quality Engineer I

Senior Quality Engineer I

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.

Principal Duties And Responsibilities

• Utilize Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Lead Material Review Board (MRB) and Nonconformance Report (NCR) process related to Quality issues (E.g., Calibration Out of tolerance, QC inspection failures, etc.). Understand and use Root Cause Analysis tools to solve Quality issues. Review / approve nonconformance investigations.
• Perform Gage R&Rs related to inspection methods. Propose new/alternate inspection methods to improved Quality, inspection time, etc.
• Perform Installation Qualification (IQ) related to inspection equipment. Review Operational and Performance Qualification protocol and reports (OQ/PQ).
• Generate Quality monthly KPI metrics and report to management.
• Perform procedure updates as required. Submit Document Change Requests related to process improvements and/or Procedure Periodic Reviews.
• Lead efforts for continuous quality and customer satisfaction improvement opportunities. Lead and perform CAPA investigations.
• Work with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities and lifecycle management.
• Write, review, and/or approve process and product validation protocols and reports, equipment qualification, engineering change orders, Test Method Validations (TMV) and software validations.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.
• Technical problem solving, failure analysis, and root cause determination.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
• Review quality inspection testing and test data. Keeps department supervisor abreast of activities and issues of the quality group.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures (FDA Part 820, ISO 13485, Part 11, etc.).
• Perform other duties assigned as needed.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Skills
Expected Areas of Competence (i.e. knowledge, skills, and abilities)

• Minimum of 5 years of experience in each of the following:
• Ability to define problems, collect data and analyze data, establish facts, and draw conclusions and recommendations.
• Strong knowledge in understanding blueprint/drawing/ and/or GD&T.
• Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Facilitates team efforts on quality engineering projects.
• Ability to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• Understanding of QSR/ISO regulations, design assurance, PFMEA, and product testing methods.
• Practical knowledge of statistics, process control, and process capability.
• Coaching, mentoring and professional development of others