Sr. Quality Engineer, Production, Medical Device

Oculus Inc•Lakewood, CO

6d•$70,000 - $85,000•Onsite

About The Position

Advanced Vision Technologies (AVT) 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. The Quality Assurance Manager 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 Assurance Manager acts as the site quality leader, partnering with Operations, corporate Quality and Production teams to promote a culture of quality, compliance, and continuous improvement.

Requirements

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.
Ability to travel approximately 5% of the time to company sites, labs, and vendor facilities.
Ability to travel internationally; valid passport required.

Nice To Haves

Experience with third-party audits, registrars, notified bodies, or sterilization processes preferred.

Responsibilities

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.
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.
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.
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.
Manage the Approved Supplier Program, including supplier qualification, monitoring, auditing, and performance evaluation.
Partner with suppliers to resolve quality issues and improve incoming material quality.
Initiate, review, approve, and monitor Change Notices to ensure quality system compliance.
Support validation activities and change control to maintain process control and product quality.
Oversee calibration and maintenance programs for inspection and measurement equipment.
Collaborate with other departments and promote teamwork within the Wave Eyecare and OCULUS Teams to deliver quality service, productivity, and business results.
Uphold and model company fundamentals at all times, contributing to a positive, respectful, and high-performing work environment.