Quality Specialist chez Highridge Medical

Job Summary:

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.

Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead entry level projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a collaborative team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Highridge to implement Highridge Quality goals.

Principal Duties and Responsibilities:

· Lead Material Review Board (MRB) and Supplier Review Board (SRB) meetings

· Process Nonconformance Reports (NCR) 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.

· 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. Support CAPA investigations and corrective/preventive action implementation.

· Lead projects to improve quality effectiveness & business efficiency

· Support the use of 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.

· 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.

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

Minimum of 2 years of experience in each of the following:

· Ability to define problems, collect data and analyze data, establish facts, and draw conclusions and recommendations.

· 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 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.

Education/Experience Requirements:

§ Minimum 2 years’ experience in a Medical Device Quality role, or an equivalent combination of education and experience.

Travel Requirements

· Up to 10%