Quality Engineer, Production, Medical Device
- Compensation
- Not disclosed
- Location
- Lakewood, CO, US
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Industrial engineering
- Posted
Skills
Must have
- Bachelor’s degree in Science, Engineering, or a related technical field preferred.
- Minimum 6+ years of experience in quality or engineering within a regulated manufacturing environment.
- Experience in medical device, ophthalmic, or contact lens manufacturing strongly preferred.
- Strong working knowledge of FDA cGMP and ISO 13485 quality systems.
- Experience leading audits, CAPA, nonconformance, complaint handling, and document control systems.
- Demonstrated ability to analyze data and apply statistical methods for quality improvement.
- Excellent written and verbal communication skills.
- Strong problem-solving skills, attention to detail, and documentation capabilities.
- Experience with third-party audits, registrars, notified bodies, or sterilization processes preferred.
- Ability to travel approximately 5% of the time to company sites, labs, and vendor facilities.
- Ability to travel internationally; valid passport required.
Full description
About UsAdvanced Vision Technologies (AVT) Advanced Vision Technologies is a specialized contact lens laboratory with extensive real-world experience, offering expert consultation to meet even the most challenging contact lens needs. Our team excels in crafting innovative designs for premium GP Contact Lenses and Specialty Soft Contact Lenses. We are dedicated to empowering Optometrists and Ophthalmologists by providing exceptional products, supplies, support, and educational resources to help their practices thrive.
Website: Advanced Vision Technologies (AVT)
Benefits
We offer Comprehensive medical, dental, and vision coverage for employees and dependents, paid time off, nine paid holidays, additional paid time off for your birthday, life insurance, short-term and long-term disability insurance, 401(k) retirement plan with company match, employee assistance program (EAP), Costco membership, employee discounts through LifeMart, company employee events, and more.
Location & Schedule
Lakewood, Colorado (on site)
Monday - Friday: 8:00am-4:30pm
Job Summary
The Quality Engineer is responsible for ensuring the integrity, compliance, and continuous improvement of the Quality Management System (QMS) supporting the manufacture of contact lenses. This role provides leadership for quality systems, regulatory compliance, product and process quality, and cross-functional quality initiatives to ensure products consistently meet FDA, ISO 13485, corporate, and customer requirements.
The Quality Engineer acts as the site quality leader, partnering with Operations, corporate Quality and Production teams to promote a culture of quality, compliance, and continuous improvement.
Essential Duties and Responsibilities (other duties may be assigned):
Quality Management System & Regulatory Compliance
- Maintain, monitor, and continuously improve the local Quality Management System in compliance with FDA cGMP, ISO 13485, and applicable regulatory requirements.
- Design, implement, and improve quality standards, procedures, and best practices across the organization.
- Ensure effective document and record control processes, including approval, revision, distribution, and archival.
- Serve as the site subject matter expert for regulatory inspections and third-party audits.
Audits, CAPA, and Risk Management
- Plan, conduct, and host internal, external, customer, and regulatory audits.
- Lead audit responses, including corrective action development, tracking, verification, and effectiveness checks.
- Serve as CAPA Coordinator, ensuring timely investigations, root cause analysis, and closure.