Quality Engineer - Healthcare Components Group

This position is located at our facility in Maryland Heights, MO.

Overview

Working as a Quality Engineer provides an exciting opportunity to contribute to cutting-edge technologies and precision-driven products. Your expertise and dedication in handling microscopic components will directly impact the quality and success of our final products. If you thrive in a detail-oriented and challenging environment, this role might be the perfect fit for you.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

The Quality Engineer is primarily responsible for ensuring materials, components, processes and manufacturing techniques produce high-quality, reliable products. Implementing methods to inspect, test, and evaluate products and the reliability of manufacturing processes. Helping to create solutions as part of a team.

Essential Duties & Responsibilities:

• Ensure materials, components, processes, and manufacturing technique produce high-quality, reliable products.
• Develop and/or assess quality inspection criteria for incoming inspection and in-process inspection to minimize risk.
• Inspect materials, equipment, processes, and products to verify conformance with specifications.
• Develop and implement methods for sampling, inspection, defect recognition, product testing and evaluation, and SPC trending utilizing statistical, engineering and quality knowledge.
• Apply statistical techniques to receiving inspection, manufacturing, and validation processes. Using statistical tools in Microsoft Excel or other SPC software.
• Interface with Production to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation, and training.
• May maintain equipment/instrument calibration log and coordinate equipment/instrument calibrations.
• Participate in solicitation, definition and review of customer specifications, product requirements, design specifications, verification and validation testing and risk assessment activities.
• Lead cross-functional teams and manage investigations into product complaints and reported quality issues. Works with suppliers, management, Engineers, and Manufacturing associates in the resolution of quality issues.
• Lead the CAPA program including leading review board and CAPA & continuous improvement projects.
• Provide training and support to quality assurance team members, focusing on systems, policies, procedures, and core processes.
• Effectively communicate and interact with customers.
• Support Quality Objectives, including analysis and regular trending of key quality system elements.

EXPERIENCE/SKILL/EDUCATIONAL REQUIREMENTS:

The ideal candidate for this role will have the following qualifications:

• Bachelor's degree in a scientific or engineering field is required.
• Minimum 3 years' experience in a quality engineering role in the medical device industry, or a related industry with manufacturing and assembly processes.
• Experience working in a regulated environment such as medical device and with a Quality Management System (ISO 9001, ISO 13485, FDA QSR, cGMP 21 CFR Part 820, ISO 14971)
• Proficient with Microsoft Office Suite
• Computer proficiency, including database management
• Excellent written and verbal communication skills
• Proficient in English, both written and verbal
• Deep knowledge of quality assurance terminology, methods, and tools
• Excellent analytical, problem-solving, and decision-making skills
• Demonstrated knowledge of testing best practices, version-control procedures, and defect management processes
• Ability to manage multiple projects within various disciplines, in a fast-paced environment.
• Experience with advanced SolidWorks or 3D CAD techniques preferred.
• Professional certification, such as Six Sigma, CQE (certified quality engineer), or CQA (certified quality auditor), preferred.

Benefits:

• Begin your journey to a healthier future with enrollment in medical, dental, vision, disability, and life insurance, starting the first of the month after date of hire.
• Secure your financial well-being with a 401k enrollment accompanied by an employer match after 30 days of employment.
• Enjoy competitive PTO accrual and a well-deserved Holiday schedule, ensuring work-life balance.

At Healthcare Components Group you'll find a welcoming and innovative environment that encourages personal growth and rewards dedication. Become part of our success story as a Production Technician, and together, let's shape the future of the company.