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. Wage Range: Commence your rewarding career with us, starting at $18 per hour. 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.
