Full Time First Article Inspector Jobs in Denver, CO

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. 

Are you looking for an inspiring career? You just found it.

Steritec Products Inc., a member of the Getinge Group, manufactures sterilization and cleaning medical device consumables using ink technology. We manufacture and print highly specialized proprietary inks that undergo specific color changes when exposed to different sterilization conditions in hospital and industrial/pharmaceutical sterilizers.
We are located in the beautiful Inverness Business Park in Englewood, CO. We offer a generous benefit package (medical, dental, vision, life, LTD, 401(k) as well as PTO, company-paid holidays and much more) all effective first day of employment!  

This QC InspectionTechnician position is an on-site, full-time, non-exempt position. Hours are Monday - Friday, 8:00am - 4:30pm (with some flexibility). 

Job Function Summary

The Quality Control Inspection Technician  is responsible for performing inspections, testing, and quality assurance activities to ensure materials and products meet established quality, performance, and regulatory requirements. This position supports product quality through laboratory testing, documentation review, data analysis, and quality system activities within an FDA- and ISO-regulated medical device manufacturing environment.

Job Functions
   Perform receiving, in-process, and final inspections of materials, components, and finished products to verify compliance with specifications and acceptance criteria. 
   Conduct laboratory and performance testing using approved procedures and testing equipment. 
   Operate inspection, measurement, and sterilization equipment, including calipers, micrometers, and other testing devices. 
   Perform First Article Inspections (FAIs) and support product evaluation activities. 
   Accurately document inspection and test results and maintain quality records in accordance with Good Documentation Practices. 
   Review Device History Records (DHRs), production records, labels, artwork, lot information, and related documentation for accuracy and compliance. 
   Prepare quality records and documents for Performance Releases, Finished Goods Releases, and nonconformance documentation as applicable. 
   Support investigations and corrections for nonconforming materials or products and support preventative action activities. 
   Maintain product retains, control samples, test samples, and quality-related data for ongoing programs such as shelf-life studies and validations. 
   Support audits, document control activities, continuous improvement initiatives, employee training, and other quality system activities as assigned. 
   Perform additional duties as assigned by Quality Management.

Required Knowledge, Skills and Abilities
   General knowledge of Inventory Control Systems and Proficiency in Microsoft Office applications, including Word, Excel, and Outlook
   Production-line and/or Quality background
   Ability to learn quickly, multitask, prioritize, and work independently or in small teams
   Strong arithmetic skills, attention to detail, and organizational skills.
   Think logically to make timely decisions based upon procedures, regulations, specifications, and scientific information.
   Good English verbal and written communication skills.

Interpersonal & Professional Skills
   Builds and maintains positive working relationships with colleagues across Operations, Quality, R&D, and other functional areas.
   Demonstrates professionalism, teamwork, and a customer-focused mindset.
   Communicates clearly and effectively, both verbally and in writing.
   Accepts feedback constructively and adapts to changing priorities.
   Exhibits reliability, accountability, and a strong commitment to quality and compliance.
   Contributes to a collaborative, respectful, and continuous improvement culture.

Minimum Requirements
   High School Diploma or equivalent required. 
   Associate degree in a science-related field preferred, or an equivalent combination of education, training, and relevant experience. 
   Experience in a quality, manufacturing, laboratory or regulated medical device environment preferred. 
   Familiarity with FDA and ISO requirements preferred

Quality Requirements
   Comply with all applicable FDA, ISO, and company quality system requirements. 
   Complete required Quality and Compliance training and maintain competency relevant to the position. 
   Follow established procedures and promptly report quality or compliance concerns through appropriate channels. 

Environmental/Safety/Physical Work Conditions
   Work is performed in laboratory, office, and manufacturing environments. 
   Frequent standing, walking, and use of computers, laboratory (sterilizers) and inspection equipment. 
   Ability to occasionally lift and move up to 20 pounds. 
   May be required to work extended hours based on business needs. 
   Must possess visual abilities including close, distance, peripheral, depth, and color vision, and the ability to adjust focus

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervision/Management Of Others:  N/A

Internal and External Contacts/Relationships
   Internal: Team members, all Getinge colleagues including the executive and leadership team, Operations, Quality, and R&D teams.  Follow up with all levels of management for clarification/approval on reports as needed.

   External: N/A

Disclaimer

All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities.  Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position,  it is not an exhaustive list of all responsibilities, duties and skills required for the position.

Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.

Requirements are representative of minimum levels of knowledge, skills and/or abilities.  To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.  Continued employment remains on an "at-will" basis.
Salary range: $25/hr - $30/hr depending on experience

#LI-JF1

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.