Sr Quality Engineer - Exempt

We are seeking a highly skilled and experienced individual to join our team in Louisville, CO. This is an exceptional opportunity to work in a vibrant location known for its innovation and quality of life.As a key member of our quality engineering team, you will be responsible for ensuring the highest standards of product quality and compliance with industry regulations. Your role will involve collaborating with various departments to maintain and improve quality protocols and processes. Must Have

• 3 years of experience in the medical device industry, with a strong background in Non-Conforming Materials Reports (NCMR), CAPA, or product quality management.
• Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
• Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
• Strong project management skills, with the ability to manage multiple priorities and deadlines.
• Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
• Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
• Proficiency in Microsoft Office Suite and quality management systems (QMS).
• Strong technical writing capability.
• Experience in Process Validation.

Nice to Have

• SAP
• Microsoft
• Nonconformance
• CAPA
• Change Order

ResponsibilitiesResponsibilities may include the following and other duties may be assigned:

• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment;conducts quality assurance tests;and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Top 3 Technical Skills Required

• Technical Procedure Review and Writing
• Understanding of NCMR requirements by FDA and ISO
• The ability to accomplish both daily tasks and longer-term tasks at the same time.

Education and Experience

• Education Required: B.S. In Engineering
• Years’Experience Required: 7-10 years of Medical Device experience

This position is full-time, requiring 40 hours per week, and is based onsite in Louisville, CO. We are looking to fill this position as soon as possible.