Key Job Responsibilities

QMS related activities

Responsible for Training System, Maintain, and ensure regulatory compliance for Synergy training activities.

Responsible for Documentation Control activities, Perform file maintenance and /or updates to operating procedures, engineering change orders, document change orders, reports and all other regulated/controlled documentation while operating and maintaining the documentation and training systems in an Electronic QMS. Aid in the release of all controlled documentation by (but not limited to) providing information, solving problems, proofing and entering information into various computerized systems. Assist in maintaining standard operational procedures, work instructions, forms and templates in Shipping, Incoming Inspection, Inventory Management and Training.

Assist in QMS compliance activities. Support audits, file submissions. Current training within an electronic QMS, as applicable. Maintaining a compliant QMS

Quality Technician activities Perform the visual, dimensional, mechanical, and/or functional aspects of plastic and metal components to help implement inspection plans, drawings, and other specification documentation. Initiate material non-conformance report s, as required. Ensure that the report contains accurate and sufficient detail of compliance or the cause(s) of failure and recommended correction(s). Work with other personnel, both internal and external suppliers, to effectively resolve inspection questions and/or issues.Assist with conducting First Article Inspections.Comply with all quality system procedures.Pick, pack and ship orders using NetSuite and Fed Ex shipping platform; all inventory is lot numbered and must be tracked accurately. Initiate, Review and Maintain quality documentation files (Device History Records (DHR) and Inspection History Records/ Shipping Records) for completeness and accuracy. Identify and document potential non-conforming product. Interface with other departments, to address and resolve any product related issues. Complete tasks accurately and on-time, paying close attention to detail.

Additional Job Requirements: Must be able to read and communicate in English. High attention to detail. Exceptional communication skills. Dependable. Ability to sit and stand for long periods of time. Proficiency with Microsoft Office products (Word, Excel, & Office). Ability to work in a team environment and independently with minimal supervision. Must be able to occasionally lift up to 30 lbs. Good Communication skills with Suppliers, Customers, Key Internal Personnel, Regulatory Agencies, top management. Good interpersonal skills.

Experience

> 2 years of professional experience in medical quality device quality assurance

Working knowledge of medical device regulatory environment, including; ISO 13485:2016, MDD/93/42/EEC, MDR 2017/745, FDA 21 CFR 820, 803, 806

2 years previous production experience with good manufacturing practices is required

1-2 years previous quality experience, Medical Device and/ or aerospace preferred (shipping, receiving inspection, manufacturing etc)

Demonstrated ability to follow Good Documentation Practices (GDP)

Basic reading and understanding of engineering drawings

Experienced knowledge on use of inspection tools preferred (calipers, micrometers, microscopes, pin gages etc.)

Job Type: Full-time

Pay: $50,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Office

Ability to Relocate:

• Louisville, CO 80027: Relocate before starting work (Required)

Work Location: In person