Quality Systems and Validations Engineer - 1st Shift

EPTAM Precision Metals is seeking a Quality Systems and Validations Engineer to join our team in Colorado Springs, CO.

We are seeking a Quality Systems and Validations Engineer who has experience in monitoring and maintaining the Quality Management System (QMS) to ensure compliance with ISO 13485 and 21 CFR part 820. This position provides focused, Quality Engineering support via communication to department managers of QMS to include complaint, CAPA, risk management, supplier quality and document control processes.

Join us as we manufacture medical implants and internal fixation devices that bring positive outcomes for our customers and life-impacting experiences for their patients.

EPTAM Precision Metals, nestled in Colorado Springs, Colorado, operates from a high-tech, 70,000-square-foot facility, specializing in medical implants and instrumentation. Our facility, accredited with FDA-registration and ISO 13485 certification, features essential resources including a Class 7 clean room, automated inspection, a validated supply chain, and a dedicated R&D cell.

At EPTAM, precision is paramount. We provide 3-, 4-, and 5-axis CNC milling, gun drilling, water jet cutting, Swiss and Super-Swiss machining, and EDM machining. With our extraordinary team and processes, we deliver unparalleled services to our employees, customers, and the end-users of our medical devices.

EPTAM Solutions, our parent company with locations nationwide, is at the Heart of Manufacturing. We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep.

Join our incredible team and reap the benefits of an employee-focused company. We excel at what we do for our customers, our employees, and the world.

JOB TITLE: Quality Systems and Validations Engineer

POSITION SUMMARY: The Quality Systems and Validations Engineer is primarily responsible for the following:

• Oversee effective implementation of the Quality Management System (QMS).
• Lead and undertake audits across all areas of the business.
• Provide training and champion the Quality Management System.
• Manage CAPA and Complaints systems and reporting performance.
• Working with Engineering planning and conducting or directing validation activities of manufacturing equipment, processes, and test methods.
• Validation activities include - but are not limited to - creating and executing validation plans, developing and conducting qualification protocols (e.g. IQ, OQ, PQ, etc.), training associates to an understanding of the significance of validation activities, training of associates required in the execution of qualification events, and analyzing & writing reports of qualification activity results.

ESSENTIAL FUNCTIONS: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Perform root cause analysis and resolve problems.
• Manage the CAPA and Customer Complaint Systems.
• Perform data analysis and trending and report such trends in management reviews.
• Oversee effective implementation of the Quality Management System, including any business accreditations.
• Maintain the Quality Management System and ensure contents are appropriate for business, in collaboration with the Quality Manager.
• Organize and manage the plant internal audit system and the corrective action reporting system.
• Conduct Quality Systems audits and assist in training/guidance to internal auditors.
• Assist/support Quality Manager during external Quality System audits.
• Provide training on Quality issues and awareness.
• Coordinate the review of Quality procedures associated with plant continuous improvement initiatives.
• Compile quality data and report on Key Performance Indicators (KPIs) to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system.
• Represent Quality Engineering as part of site validation team new product introduction (NPI) and existing product transfer programs.
• Acquiring and understanding the company's, customers', and regulatory requirements for validation activities, and planning validation activities to maintain compliance to the same requirements.
• Receiving or acquiring product or process specifications, helping and/or creating validation plans for the manufacturing cycles to accomplish production of the same. A Quality Stems and Validation Engineer must be able to read technical drawings, standards, and articles.
• Acquiring equipment and process specifications and descriptions by coordinating with Manufacturing, Process, and Quality Engineers to create validation plans.
• Designing, developing and creating validation plans and accompanying qualification protocols, and negotiating the approval of qualification protocols prior to execution, including writing qualification reports and executive summaries. This includes validation plans for processing and test equipment (from commercially-available-off-the-shelf [COTS] to custom, in-house designed equipment), product specific manufacturing processes, test methods (i.e. analytical methods, mechanical properties testing, etc.), and software.
• Maintaining the company's Validation Master Plan. This includes contributing to decisions regarding changes and revalidation as needed according to the validation procedure.
• Applying statistically valid methods for determining qualification sample sizes, capability studies, and for quantitatively/statistically analyzing the results of qualification events.
• Contributing to the creation or development of manufacturing cycle risk assessments (i.e. pFMEA), control plans, continual improvement processes (CIP), and corrective and preventive actions (CAPA).
• Working closely with the Production, Quality & Inspection, and Engineering Departments on process problem solving (identifying root cause and assisting with solutions requiring validation or revalidation) to various equipment, process, and test methods.
• Assessing the validation status equipment and processes and determining when and to what extent validation activities are/will be required.
• Reporting to Engineering and company Top Management on validation project status and progress.
• Documenting validation activities using Microsoft Word & Excel as well as performing statistical analysis using Minitab or equivalent.

OTHER RESPONSIBILITIES:

• Promote the use of customer preferred techniques for continuous improvement such as Six-Sigma, Poka-Yoke (Error Proofing), and Measurement System Analysis.
• Keep up with current and developing manufacturing and engineering trends that concern product quality.
• Support and lead process improvement activities.
• Understand the sensitivity of the data handled by systems under your control and take appropriate measures to protect it.

EDUCATION AND EXPERIENCE:

• EDUCATION: Bachelor's degree in an engineering field, or relevant technical field (STEM) preferred, but not required.
• EXPERIENCE: 3 year(s) of progressive experience in manufacturing and/or quality in an FDA, and ISO 13485 operating environment, demonstrating acumen, and understanding of QMS and Operations; equivalent combinations or education and experience accepted OR demonstrated ability to execute the Essential Functions for this position.
• LICENSES, CERTIFICATIONS AND/ REGISTRATIONS: None

OTHER QUALIFICATIONS AND SKILLS:

• Strong knowledge of Medical Device Industry, FDA, and ISO 13485 requirements.
• Excellent written and verbal communication skills, strong interpersonal skills; position is customer facing.
• Ability to engage with corporate officers in broader organizational strategic planning; collaborate with the division leaders to achieve business goals and objectives.
• Comply with FDA QSRS, ISO-13485 and other regulatory requirements including the Health, Safety and Environmental Policies Employee must be able to relate to other people beyond giving and receiving instruction. Can get along with co-workers or peers and respond appropriately to feedback from a supervisor in a professional manner.

ADP1151

2XB-240418-141

1st Shift is 7:00am to 3:30pm Monday through Friday