Quality Engineer - Manufacturing
Description
- Leads investigations into manufacturing production quality issues, including but not limited to nonconformances, line failures, and yield losses, to identify root causes and drive effective corrective and preventive actions (CAPA) by working cross functionally with different team.
- Partners with manufacturing teams to develop and maintain robust process controls that improve yield, reduce scrap/rework, and enhance product reliability.
- Develops, validates, and sustains in-process inspection methods, test procedures, and acceptance criteria.
- Establish and maintains statistical process control (SPC), measurement system analysis (MSA), and gage repeatability and reproducibility (GR&R) studies to ensure reliable data-driven decisions.
- Drives structured problem-solving activities to support manufacturing teams in troubleshooting quality issues. Utilizes data-driven tools and methodologies such as 5 Whys; Ishikawa diagram; Eight Disciplines (8D); and Define, Measure, Analyze, Improve, Control (DMAIC).
- Analyze trends in production data, nonconformances, and complaints to identify systemic issues and improvement opportunities.
- Leads customer complaint investigations from manufacturing perspective, collaborating with cross-functional stakeholders to provide manufacturing input, verify root causes, and implement process improvements that prevent recurrence.
- Assist Manufacturing Engineers with control plan and process validations (installation qualification (IQ), Operational Qualification (OQ), and performance qualification (PQ)).
- Participates in risk management activities to ensure process risks are identified and mitigated.
- Provide training and guidance to manufacturing staff on quality standards, defect prevention, and process control.
- Ensures compliance with ISO 13485, FDA 21 CFR Part 820, and company procedures through strong process monitoring and documentation.
- Performs other related duties and projects as business needs require at direction of management.
- Bachelor of Science in Manufacturing, Mechanical, or Materials Engineering, or related field. Master’s degree in related field a plus.
- Minimum two (2) years of experience in manufacturing quality engineering within a regulated industry such as medical devices, pharmaceuticals, or similar industry.
- Demonstrated experience with CAPA, root cause analysis, and problem-solving methodologies (8D, 5 Whys, and Ishikawa diagram).
- Hands-on experience with statistical process control (SPC), measurement system analysis (MSA), and Gage repeatability and reproducibility (GR&R) studies.
- Experience with complaint handling and trends in a medical device environment.
- ASQ Certified Quality Engineer or equivalent certificate preferred.
- Demonstrated knowledge of policies, procedures, and guidelines relevant to regulatory and quality compliance, including ISO 13485 and FDA 21 CFR Part 820.
- Familiarity with risk management per ISO 14971.
- Demonstrated knowledge of quality systems.
- Proficiency with data analysis tools.
- Familiarity with lean manufacturing and Six Sigma methodologies
- Ability to frequently lift, carry, push and/or pull up to twenty-five (25) pounds.
Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!
In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!
Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.
Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.