Quality Engineer

DEPARTMENT: Quality

REPORTS TO: Quality manager

STATUS:

LOCATION: Denver, CO

Fathom is one of the largest digital manufacturing platforms offering on-demand manufacturing in North America. With more than 90 large-platform industrial-grade 3D printing machines and a national footprint with more than 450,000 square feet of manufacturing capacity across 12 facilities, Fathom seamlessly blends in-house capabilities across plastic and metal additive technologies, CNC machining, injection molding & tooling, urethane casting, sheet metal fabrication, and design and engineering.

With over 50 years of industry experience, Fathom is at the forefront of the industry 4.0 digital manufacturing revolution serving clients in the technology, defense, aerospace, medical, automotive and IOT sectors. Fathom's extensive certifications include ISO 9001:2015, ISO 9001:2015 Design, ISO 13485:2016, AS9100:2016, NIST 800-171 and ITAR.

Position Summary:

The incumbent must have strong leadership abilities, working knowledge of Quality Engineering skills, Lean Sigma methodology, Core Tools, QMS, ISO 9001:2015 standards and Quality principals, problem solving skills, strong verbal, and written communication skills.

The incumbent will be directly responsible for supervising and supporting all Quality operations activities in support of manufacturing.

Responsibilities:

• Direct all activities in support, proper execution of process validations and new product transfers to manufacturing to assure regulatory compliance.
• Provide expert opinion and direction for setting validation strategy and structure.
• Evaluate Engineering tests in support of validation or investigational studies
• Interface with engineering to introduce changes in process or product
• Interface with Engineering on projects related to new products or product changes
• Ensure that quality inspection plans are appropriate for the product & process
• Ensure all elements of the quality system as they apply to operations are in compliance; CAPA, Training, Documentation, Calibration, Environmental.
• Write, review, and approve procedures that apply to Quality operations
• Manage, and Participate in the internal audit program (Internal auditor a plus)
• Participate and/or champion Process Excellence programs
• Interface with customer audits, and registration bodies
• Will champion other activities within the organization as deemed necessary and appropriate

Required Skills:

• Must be a team player with good interpersonal skills.
• Must have excellent communication & negotiation skills.
• ERP systems knowledge and experience

EDUCATION/CERTIFICATION:

• Bachelor's in engineering; Masters is a plus
• Certifications: QE, Six Sigma Green, or Black Belt