Position Title:

Senior Quality Engineer

Job Description: 

HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice, HuFriedyGroup provides a unique combination of world class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance and enhanced safety for dental professionals and their patients. Working at HuFriedyGroup is so much more than a job, as every employee has a part in driving and supporting the organization’s inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.

Position Summary:

The Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: ISO 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MOR, and other applicable standards. This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of HuFriedyGroup quality systems.

Duties:

1. Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
2. Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
3. Leads process and product corrective actions and problem-solving activities.
4. Reviews the current quality system and recommend/ implement improvements as needed.
5. Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
6. Leads projects focused on quality system, product quality and service quality improvements.
7. Develops analyses and reports on the performance of the quality system.
8. Leads supplier audits and corrective actions.
9. Leads and supports internal and external quality system audits.
10. Instructs other HuFriedyGroup employees in quality principles, effective corrective actions, and valid statistical techniques.
11. Collaborates with other departments and facilities within the company on quality related issues.
12. Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
13. Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
14. Perform all other duties as assigned.

Functional Knowledge, Skills & Abilities:

• Bachelor's Degree in Engineering or related field required; advanced degree is a plus
• Minimum work experience required in addition to education above: 2-3 Years of production Quality Engineering experience
• 6-10 years combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Experience working in an ISO certified environment required. 6-10 years.
• 2-3 years of experience with medical device or other regulated industries.
• Excellent problem-solving skills
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated excellent organizational, oral, and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Experience with statistical analysis software and Visio preferred.
• People managing (preferred)