Quality Engineer

Job Type
Full-time
Description
Job Title: Quality Engineer
Reports To: Operations, Regulatory or Quality Engineering Management
About Lumitex
Join us as we strive to become THE global leader in medical device lighting and Improve Life with Light! For nearly 40 years, Lumitex has been at the forefront of revolutionizing medical lighting solutions. We collaborate with our customers to integrate light into applications or leverage light for the treatment or prevention of specific medical conditions. We assist them in overcoming their most complex lighting challenges, delivering customized solutions, and establishing ourselves as their trusted lighting experts. We believe that ideas can change the world, and our customers should not be bound by technical limitations. Our comprehensive range of services, including product development, engineering expertise, and lighting system production, combine to optimize light and improve the standard of patient care. Life at Lumitex begins with our Mission to Improve Life with Light! This guiding mission shapes our daily work, inspiring collaboration, fostering innovation, and ultimately making the world a brighter place. We are currently seeking a Quality Engineer to join our team and play a pivotal role in our journey. Come grow with us and light your own path!
Job purpose
This role will focus on providing thorough and practical solutions to a wide range of technical problems through the application of quality, statistical, and engineering disciplines.
Duties and responsibilities

• Participate in design quality activities; develop and implement part and process qualification requirements to ensure that delivered products meet specification and quality/reliability requirements. (Control Plans, Inspections Plans and other quality elements)
• Lead and/or support executing, documenting, and investigating supplier and internal non-conformance reports (NCRs).
• Lead and/or support the Customer Return (RMA) process and initiate investigation efforts to address and reduce customer complaints through effective root cause investigation and corrective action.
• Lead and/or support CAPA controls, completion, implementation and effectiveness stages.
• Lead and/or support factory PPAP and IQ/OQ/PQ actions to maintain high quality production.
• Support risk analysis activities. Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode effects analysis).
• Support internal auditing program - conduct process, product and QMS internal audits. Assist in managing QMS auditing program as needed.
• Support inspection team in daily functions.
• Use quality tools and analysis to formulate/facilitate quality plans for products.
• Develop, maintain, and ensure compliance with quality assurance programs, policies, processes, and procedures under customer, internal, ISO 9001, FDA, ISO 13485, and regulatory/legal requirements.
• Review and approve changes in product, documentation and processes through the Change Control Process.
• Interact regularly with engineering, manufacturing and commercial functions to establish quality standards for raw material, work in process and finished products and ensure sufficient process capability to consistently meet those standards.

Requirements
Qualifications

• Bachelor's degree in engineering, science, or equivalent.
• Associate's degree in quality or ASQ Quality Engineer certification preferred.
• 3-5 years progressive quality assurance experience
• Ability to demonstrate strong problem-solving skills and attention to detail.
• Demonstrates knowledge of ISO and Lean, PPAP's, PFMEA, and Control Plans, tools and techniques preferred.
• Self-motivated with critical attention to detail, deadlines, and reporting.

Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to speak, stand, talk, walk, sit, see, and hear (corrected or uncorrected).
• The employee is occasionally required to climb, stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 50 pounds.

Direct Reports
None
Conclusion
This job description is intended to convey information essential to understanding the scope of the job and the general nature and level of work performed within this job. However, this job description is not intended to be an exhaustive list of responsibilities, duties, qualifications or physical demands associated with the position.
Lumitex is an equal opportunity employer and does not discriminate on the basis of race, color, religion, gender (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state and local laws. Lumitex complies with applicable state and local laws governing nondiscrimination in employment.