Quality Engineer, Production, Medical Device

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Full Time Professional Lakewood, CO, US

Salary Range: $70,000.00 To $85,000.00 Annually

Advanced 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.

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 Life Mart, company employee events, and more.

Monday - Friday: 8:00am-4:30pm

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.

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.
• Manage Nonconforming Material (NCM) processes, including investigation, disposition, and documentation.

Product Quality & Continuous Improvement

• Develop and oversee inspection methods, quality control strategies, and acceptance criteria.
• Analyze quality and process data using statistical methods to identify trends, risks, and improvement opportunities.
• Monitor, track, and trend key quality performance indicators (KPIs).
• Drive continuous improvement initiatives to enhance product quality and process capability.

Complaints & Post-Market Quality

• Manage the complaint handling process, including intake, investigation, documentation, and regulatory reporting support as required.
• Ensure timely and compliant closure of complaints in line with regulatory expectations.

Supplier Quality & Vendor Management

• Manage the Approved Supplier Program, including supplier qualification, monitoring, auditing, and performance evaluation.
• Partner with suppliers to resolve quality…