Sr. Quality Engineer, Production, Medical Device
1 month ago
Denver
Job Description About Us 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. 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 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. 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., • 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 issues and improve incoming material quality. Change Management, Validation & Equipment • 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 Collaboration and Company Fundamentals • 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.Qualifications, • 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.Physical Demands and Work environment:, • Work is performed in both an office and in a precision manufacturing clean environment., • Exposure to standard office conditions (computers, phones, office equipment) as well as manufacturing conditions, such as moderate noise levels, dust, and chemicals associated with production processes, • Regularly required to stand, walk, bend, twist and reach throughout the workday., • Frequently required to lift, move, and carry items up to 50 lbs.; occasionally up to 50 lbs., • Ability to safely handle delicate and sensitive equipment., • The company provides a smoke and vape-free environment on company premises for its employees, customers, and visitors. Scope and changes: The job description is not intended to cover every single requirement of the job and that the company reserves the right to change job duties at any time.
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