Quality Engineer

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.

Job Summary

The Design Quality Engineer plays a key technical role within Highridge Medical to ensure spinal implant and instrument systems meet all applicable regulatory, safety, and performance requirements. The Design Quality Engineer partners closely with Development, Research, Regulatory Affairs, Marketing, and others to guide design decisions, establish robust design inputs/outputs, develop verification and validation (V&V) strategies, establish risk management files, and maintain compliance to external regulations and internal procedures. .

Principal Duties And Responsibilities

• Serves as the design quality representative on new product development and sustaining engineering teams, ensuring compliance with internal design control processes and external standards and regulations.
• Guides the planning, execution, and documentation of design control activities, ensuring complete and compliant design history files (DHFs).
• Lead Quality related problem solving, including issue investigation, root cause analysis, and data analysis, gathering relevant, factual information.
• Formulates and refines procedures, specifications, and standards for Highridge Medical products and processes.
• Provides leadership for quality engineering projects including CAPAs and continuous improvement projects.
• Lead risk management activities in accordance with ISO 14971.
• Work effectively/ productively with all departments by developing a team atmosphere.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Skills

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• 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.
• Microsoft Office Suite
• Ability to interpret engineering drawings and understand geometric dimensioning and tolerancing (GD&T) principles.
• Working understanding of ISO 13485 and ISO 14971
• Experience with the MDSAP program and working knowledge of FDA and EU medical device regulations, design assurance, risk analysis techniques, and product testing methods.
• Knowledgeable in statistical analysis, including design of experiments, hypotheses testing, and sample plans.

Education/Experience Requirements

• B.S. in engineering or an alternative Bachelor’s degree program plus 1-3 years experience in a Quality Engineering role, or an equivalent combination of education and experience.
• Medical device, particularly Orthopedic industry, experience preferred. Certification as a quality engineer (e.g. CQE) a plus.

Travel Requirements

Up to 20%