Highridge Medical · 3 hours ago
Quality Engineer
Westminster, CO, US
Full-time
Onsite
Entry, Mid Level
$56K/yr - $73K/yr
1+ years expHighridge Medical creates innovative spinal solutions, and they are seeking a Design Quality Engineer to ensure spinal implant and instrument systems meet regulatory and performance requirements. The role involves collaborating with various departments to guide design decisions, establish verification strategies, and maintain compliance with regulations.
ManufacturingMedical
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
Qualification
Required
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
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
Preferred
Medical device, particularly Orthopedic industry, experience preferred
Certification as a quality engineer (e.g. CQE) a plus
Company
Highridge Medical
Highridge Medical is a medical device company focused on designing and commercializing novel and proprietary products and solutions. It is a sub-organization of H.I.G. Capital.
1001-5000 employees
H1B Sponsorship
Highridge Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2023-12-18Acquired
Recent News
2026-01-21
2025-11-27
Company data provided by crunchbase