QA Lab Technician (Onsite) - Englewood, 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 QA Laboratory Technician position is an on-site, full-time, non-exempt position. Hours are Monday – Friday, 8:00am – 4:30pm (with some flexibility). 

Job Function Summary:
This person is responsible for the testing and evaluation of chemical indicators being produced daily. This process requires the ability to operate all sterilization type equipment and evaluate data for proper product performance. This person needs to be a reliable, self-starter that can work independently in a laboratory testing lab environment.

Job Functions:
•    Operation of all types of sterilization equipment and any other equipment necessary to assure that components and products meet specifications.
•    Performance of test methods for all chemical indicators, bowie-dick test packs, and biological test packs.
•    In-process and final performance testing of key components for proper function.
•    Accurately review and fill out proper paperwork.
•    Maintenance, organization, and storage of all product retain, testing and control samples.
•    Review product labels for correct use and lot information as well as indicator graphic proofing.
•    Analyze and record data for monthly shelf life protocol.
•    Other QC duties as designated by the QA Supervisor.

Required Knowledge, Skills and Abilities:
•    General knowledge of Word, Excel and Outlook.
•    Ability to learn quickly and increase skill level as required by the demands of the job.
•    Must have accurate math skills.
•    Strong attention to detail and highly organized.
•    Must be able to think logically, evaluate and make decisions based upon procedures, regulations, specifications and scientific information, as required.
•    Must have the ability to work independently or in small groups.
•    Ability to multitask.
•    Good verbal and written communication skills.
•    Motivated and willing to comply with company policies and management direction.
•    Must NOT have any color deficiencies.

Minimum Requirements:
•    4-year college degree, preferably in medical device, biology or bio-chemistry.
•    Practical experience working in a testing laboratory or with testing equipment.
•    FDA and ISO regulated knowledge.

Quality Requirements
•    Build Quality into all aspects of work.
•    Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to your job function).
•    You must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
•    Attend all required Quality & Compliance training at the specified interval.
•    Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
•    Must practice verbatim compliance (exact compliance, no interpretation) with corporate Quality and Regulatory procedures (As applicable to your job function).
•    If your job description requires customer facing activities, you must thoroughly understand and comply with the Customer complaint reporting process and complaint procedures (As applicable to your job function).
•    Must be able to promptly report any non-compliance issues to Director QA, RA, Compliance officer or appropriate administrator, including the Compliance Hotline.
•    Must be competent with 21 CFR 820 and any other applicable federal regulations, and Quality standards (As applicable to your job function).

Environmental/Safety/Physical Work Conditions:
•    Ensures environmental consciousness and safe practices are exhibited in decisions.
•    Duties are mainly performed in an office environment.
•    May work extended hours during peak business cycles.
•    The individual must occasionally lift and/or move up to 15 lbs.
•    Ability to utilize computer and telephone equipment and other related office accessories/devices to complete assignments.
•    While performing the duties of this job, the employee is frequently required to stand, walk and sit.
•    The employee must have use of hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; speak and hear.
•    Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
•    May work extended hours during peak business cycles.
•    While performing the duties of this job, the employee is frequently required to stand, walk and sit.

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.

Houlry Range:  $20 - 25/hr DOE

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.