Quality Assurance Technician - Merrimack, NH

Company: Getinge
Location: Merrimack
Posted on: November 20, 2023

Job Description:

At Getinge we have the passion to perform



Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives.

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


Hybrid - Eligible to work from home 1 - 2 days/week.



Job Overview



Provide support for Quality Assurance Department with CAPA Request and CAPA activities under the guidance of Quality Assurance Engineers and the Quality Assurance manager.



Job Responsibilities and Essential Duties

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• (60%)
  
  
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  • Perform CAPA Verification of Implementation (VOI) and Verification of Effectiveness (VOE) activities and write memo reports with results.
    
  • Perform CAPA Query activities and document results.
    
  • Enter and process CAPA documentation within the TrackWise electronic system.
    
  • Review CAPA records and documentation for completion and accuracy.
    
  • Export data and update electronic (Excel) CAPA log sheets.
    
  • Provide training and assistance on CAPA electronic system and CAPA Review Board process.
    
    
    
    
    
    
    
    • 
      
    • (30%)
      
      
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      • Schedule and facilitate CAPA Review Board Meetings and take meeting minutes.
        
      • Schedule and facilitate other CAPA meetings as required and take minutes.
        
      • Communicate reminders to personnel on due dates of actions.
        
      • Follow-up on status and verify required tasks are being completed on-time.
        
      • Prepare charts and reports using Microsoft Office (Excel, PowerPoint).
        
        
        
        
        
        
        
        • 
          
        • (10%)
          
          
          • 
            
          • Provide backroom support for external audits.
            
          • Perform other duties, as assigned to support department goals.
            
            
            
            
            
            
            
            
            
            
            Minimum Requirements
            
            
            • 
              
            • High School Diploma or GED plus one year of college level courses, preferably in Engineering or Science, or equivalent work experience.
              
            • Work experience in a Quality Management System environment preferred.
              
              
              
              
              Required Knowledge, Skills and Abilities
              
              
              
              
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              • High level of attention to detail and accuracy.
                
              • Strong interpersonal and communication skills.
                
              • Strong organization skills with the ability to work on multiple tasks/projects.
                
              • Ability to prepare and write well written reports.
                
              • Ability to interact and communicate with all levels of personnel from various functions.
                
              • Ability to learn new software applications.
                
              • Intermediate skills with MS Office applications (Outlook/Word/Excel/PowerPoint).
                
                
                
                
                Supervision/Management Of Others:
                
                
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                • Not a supervisory/management role.
                  
                  
                  
                  
                  Internal and External Contacts/Relationships
                  
                  
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                  • Interaction with Quality Assurance group and cross-functional departments.
                    
                  • May have interactions with external customers and representatives from regulatory agencies.
                    
                    
                    
                    
                    Environmental/Safety/Physical Work Conditions
                    
                    
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                    • Ensures environmental consciousness and safe practices are exhibited in decisions
                      
                    • Use of computer and telephone equipment and other related office accessories/devices to complete assignments
                      
                    • May work extended hours during peak business cycles
                      
                      
                      
                      
                      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.
                      
                      
                      
                      Permissions: Each organization shall establish the appropriate authority, and interrelation of all employees who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
                      
                      
                      
                      Disclaimer: The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
                      
                      
                      About us
                      
                      Getinge is on an excitingtransformation journey constantly looking for new ways to innovate together with our customersto meet the healthcare challenges of the future. Our passionatepeople hold our brand promise 'Passion for Life' close to heart.
                      
                      
                      
                      Ifyoushareourpassionandbelievethatsavinglivesisthegreatestjobinthe world, thenwelook forwardtoreceivingyourapplication and resume. We hope you will join us on our journey to become the world's most respected and trusted MedTec company.
                      
                      
                      
                      Benefits at Getinge:
                      
                      
                      
                      At Getinge, we offer a comprehensive benefits package, which includes:
                      
                      
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                      • Health, Dental, and Vision insurance benefits
                        
                      • 401k plan with company match
                        
                      • Paid Time Off
                        
                      • Wellness initiative & Health Assistance Resources
                        
                      • Life Insurance
                        
                      • Short and Long Term Disability Benefits
                        
                      • Health and Dependent Care Flexible Spending Accounts
                        
                      • Commuter Benefits
                        
                      • Parental and Caregiver Leave
                        
                      • Tuition Reimbursement
                        
                        
                        
                        
                        Getinge 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.

Keywords: Getinge, New England , Quality Assurance Technician - Merrimack, NH, Professions , Merrimack, Northeast