Senior Quality Engineer

Job Summary

We are seeking a Design Quality Engineer that will play a key technical role within Highridge Medical to ensure spinal implant and instrument systems meet all applicable quality, regulatory, safety, and performance requirements.

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.
• 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.
• Collaborate effectively/ productively with all departments by developing a team atmosphere.

Expected Areas of Competence

• 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.
• Able to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• Able 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 with certification as a quality engineer (e.g. CQE) plus 4-6 years experience in a Quality Engineering role, or an equivalent combination of education and experience.