Sr. Quality Engineer II

Job Summary

Responsible for gathering relevant, factual information and data to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time‑dependent sequencing with realistic timelines. Work effectively and productively with all departments by developing a team atmosphere. Ensure that products conform to established requirements and standards through appropriate audit, inspection, and test activities.

Interact with many functional departments, suppliers, and experts outside Highridge Medical to implement Highridge Medical quality goals.

• Evaluate process methods and equipment to meet performance and quality requirements.
• Establish quality plans for equipment and processes for general and specific product performance needs.
• Monitor performance of processes to meet standards.
• Apply ISO and QSR requirements to processes and procedures for Highridge Medical and outside suppliers.
• Work with suppliers on new product introduction to ensure quality and performance requirements are fulfilled.
• Assist Manufacturing, Sourcing and Development in the interpretation and application of regulations.
• Develop and maintain department and project budgets.

• Ability to work within a team environment and build relationships outside the department and the company (suppliers, regulatory agencies, etc.).
• Facilitate team efforts on quality engineering projects.
• Deliver, meet deadlines and have a results orientation.
• Communicate orally and in written form to multiple levels of the company.
• Proficiency with Microsoft Office Suite.
• Expert knowledge of blueprint reading and geometric dimensioning and tolerancing.
• Understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods.
• Ability to use optical comparators and CMMs.
• Knowledge of statistics, process control, and process capability.
• Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for correction.
• Strong knowledge base of existing Highridge Medical products and basic understanding of competitive products.

At least a B.S. in engineering or related degree program. Certification as a quality engineer (e.g., ASQ CQE) or the Reliability Engineer Certification (ASQ CRE) preferred. 5+ years’ experience in a Quality Engineering role; medical device experience strongly preferred. Combination of education and experience may be considered.

Up to 30%.

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.