Quality Specialist II (Hybrid) - 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!  

HYBRID:  Eligible to work from home 1 - 2 days/week

 

Job Function Summary:
The Quality Specialist is responsible for managing the daily functions of the Quality operations pertaining to the production of manufactured product and Quality Management System Processes, including Medical Devices. Responsible for performing Quality Activities per the local Quality Management System, acting as a subject matter expert with cross functional teams within the organization. The Quality Specialist will report directly to the Local Quality Manager for the SteriTec Site in Englewood, Colorado.

 

Job Functions:
•    Manage customer feedback, post market surveillance, and complaints per local and corporate procedures.
•    Work with cross functional teams for CAPA and Nonconformance processes and ensure compliance and effectiveness of activities performed.
•    Act as a Subject Matter Expert representing Quality and Regulatory for Design and Process Engineering Activities, i.e., Requirements Development, Design and Process Verification and Validation Activities.
•    Act as an Independent Reviewer to Engineering and Change Management Activities.
•    Gather data for key Quality Processes for Trending and Quality Data Review.
•    Assist with Risk Management Activities.
•    Non-Conforming Item Report processing.
•    Product Release Activities.
•    Monitor the Implementation and Verification of Effectiveness of Corrective Actions.
•    Perform Internal Audits and work with cross functional teams on audit related actions.
•    Assist with Supplier Quality Management Activities.
•    Prepare and assist in external audits and inspections.
•    Other Quality Assurance activities as designated by the Manager of Quality Assurance and Regulatory Affairs.

 

Required Knowledge, Skills and Abilities:
•    In-depth knowledge of ISO 13485 and FDA 21CFR820 requirements. Knowledge of EU MDR beneficial
•    Analytical mindset with strong problem solving skills  
•    High level of attention to detail and accuracy 
•    Strong computer skills, including MS Office applications (Word/Excel) and Microsoft Project are required
•    Proficiency in relevant software applications (e.g., document management systems, quality management systems) is a plus
•    Demonstrated leadership experience with the ability to lead and develop a team, drive accountability, and foster a culture of quality and compliance 
•    Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, regulatory agencies, and external stakeholders

 

Minimum Requirements:
•    Bachelor’s Degree or equivalent work experience 
•    A minimum of five years related Quality Management experience in an FDA and ISO regulated environment 

 

Quality Requirements: 
•    Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
•    Ensure compliance to all FDA and Global Quality & Compliance regulations (As applicable to the job function).
•    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.

 

Environmental/Safety/Physical Work Conditions:  
•    This is an onsite position, normal business hours. May