Senior Quality Engineer II

Highridge Medical LLC; Olive Branch (MS); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Job summary

Highridge Medical is seeking a Senior Quality Engineer I to lead quality engineering activities across the product lifecycle in spine solutions. You will drive QA compliance and collaboration with cross-functional teams to ensure patient safety and product quality.

Key tasks include MRB/NCR management, CAPA investigations, statistical analysis (SPC/DOE), and protocol development for IQ/OQ/PQ. Travel up to 10% is expected with a focus on continuous improvement.

Qualifications

• Minimum of 5 years of experience in quality engineering.
• Strong knowledge in GD&T and QA regulations (FDA/ISO 13485).
• Experience with CAPA, MRB/NCR processes.
• Statistical methods: SPC, DOE, and data-driven decision making.

Responsibilities

• Lead MRB and NCR processes for quality issues across the product lifecycle.
• Perform root cause analysis and CAPA investigations; drive improvements.
• Develop and qualify inspection methods; review IQ/OQ/PQ protocols and reports.
• Generate quality KPIs and report to management; collaborate with R&D and Operations.

Job description

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

• 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

Preferred CQE and/or Green belt certification Six sigma and/or knowledge of Process Excellence tools

B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE) 3-5 years’ experience in a Quality Engineering role, or an equivalent combination of education and experience.

Travel Requirements Up to 10%

Salary Range $80,000 -100,000 DOE

Welcome to the Highridge Medical's Career Page. Highridge Medical is committed to improving spine care by partnering with the surgeon community to drive innovation. The company has a compelling and comprehensive portfolio supported by extensive clinical evidence, including solutions for complex spine, motion preservation, minimally invasive surgery, biologics, and enabling technologies. For additional information, please visit www.highridgemedical.com.