Sr. Quality Engineer I

HIGHRIDGE Inc.; Westminster (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

Highridge Medical is seeking a Quality Engineer to gather data, solve quality problems, and lead improvement projects. You will ensure products meet established requirements through audits, inspections, and testing, while collaborating with suppliers and internal teams to implement quality goals.

The role requires a BS in engineering, 5+ years in quality engineering (medical device preferred), and ASQ CQE/CRE certification is a plus.

Qualifications

• At least 5 years in a Quality Engineering role; medical device experience preferred.
• Understanding of ISO/QSR regulations and design assurance practices.
• Experience with FMEA, statistics, process control, and metrology.

Responsibilities

• Evaluate processes and equipment to meet performance and quality requirements.
• Establish quality plans for equipment and processes; monitor performance.
• Apply ISO/QSR requirements to processes; collaborate with suppliers on new product introductions.
• Assist Manufacturing, Sourcing and Development with regulatory interpretations.
• Develop and maintain department and project budgets.

Skills

Team collaboration

Quality engineering

Project planning

Communication

Statistics

GD&T knowledge

QSR/ISO regulations

FMEA

Metrology

Education

B.S. in engineering or related field

ASQ CQE or CRE preferred

5+ years in Quality Engineering

Tools

Optical comparators

CMMs

Job description

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 projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a 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 Medical to implement Highridge Medical Quality goals.

Principal Duties and Responsibilities:

• Evaluating process methods and equipment to meet performance and quality requirements.
• Establishing quality plans for equipment and processes for general and specific product performance needs
• Monitoring performance of processes to a standards
• Applying ISO and QSR requirements to processes and procedures for Highridge Medical and outside suppliers; Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled
• Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations
• Developing and maintaining department and project budgets

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.

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

• 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, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able 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 how to correct it.
• Thorough knowledge base of existing Highridge Medical products and a basic understanding of competitive products

Education/Experience Requirements

• At least 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 strongly preferred
• Combination of education and experience may be considered.