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Senior Quality Assurance Specialist - Englewood, CO in Englewood, CO at Getinge

Date Posted: 5/10/2019

Job Snapshot

  • Employee Type:
  • Location:
    Englewood, CO
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. A career at Getinge provides career opportunities that both inspire and challenge. Here, you can make a difference every day.

Getinge (Denver), located in the beautiful Inverness Business Park is looking for a full-time, Senior Quality Assurance Specialist to join our Quality team. We are a producer of Class II medical devices. Enjoy a progressive environment, casual business attire, monthly employee luncheons, free parking and a generous benefit package. 

Job Function Summary:
The Senior Quality Assurance Specialist will perform a wide variety of internal audits/tasks to ensure compliance with applicable regulatory requirements, training programs, data and documentation reviews and analysis.  

Job Functions: 
•    Provide guidance to assist in the development, implementation and maintenance of the Quality Management System
•    Lead internal audits as the head auditor.
•    Manage external third party auditors to conduct internal audits as needed.
•    As appropriate, establish an audit team and manage the team to perform audits.
•    Ensure that annual audits are completed in compliance with regulatory requirements.
•    Submit Audit Reports in a timely manner.
•    Ensure that identified non-conformances are addressed and closed by the auditee within established time lines.
•    Perform effectiveness checks of CAPAs.
•    Provide compliance guidance for due diligence/integration and validation of new processes
•    Provide quality compliance mentoring and training
•    Provide data and trend analysis on Quality Data records such as complaints and audit analysis
•    Responsible for product complaint investigations and reporting
•    Reviews, develops, and writes QA and QC procedures as needed
•    Provide compliance support during FDA and other Regulatory Inspections

•    Follow up and assist with special auditing projects.
•    Assists in special projects as needed.  
•    Contributes to team effort by accomplishing related duties as requested.

Required Knowledge, Skills and Abilities:  
•    Excellent written and verbal communications skills.
•    Strong customer service focused work ethic and attention to detail.  
•    Professional interpersonal skills necessary to interact with external customer and internal contacts.
•    Demonstrated time management and organizational skills; ability to work independently and as part of a + team.
•    Strong computer skills including MS Office applications are required.  

Minimum Requirements: 
•    BS or MS in Engineering or Sciences or equivalent work experience required.
•    Minimum of five years working in Regulatory Affairs, Compliance or Quality Assurance. 
•    Must be able to think logically, evaluate and make decisions based upon procedures, regulations, specifications and scientific information, as required
•    Experience in 21 CFR 820 regulation
•    Experience in ISO 9001, 13485, 14001 Lead Auditor Training
•    Experience in new process development
•    Experience in Medical Device manufacturing processes 

Quality Requirements:  
•    Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
•    Ensure compliance to all FDA and Worldwide 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:  
•    Ensures environmental consciousness and safe practices are exhibited in decisions.
•    Duties are performed in an office environment.
•    Requires manual coordination and vision to operate PC and telephone. 
•    Hearing necessary to receive and reply to outside contacts and employees. 
•    Ability to speak clearly in order to communicate with outside contacts and employees in person and on the telephone. 
•    Must be willing to work in a sitting position for long periods of time. 
•    Some bending, stooping, reaching and lifting (up to 15 pounds) is required. 
•    Willingness to frequently move to various locations within and outside of the building.

 Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.



We look forward to receiving your application.