Quality Systems Assistant

Job function summary

Quality Systems Assistant primary function is maintenance and review of the quality systems processes to ensure compliance and improvements to the system in collaboration with Quality Systems Engineer. Additionally to support document control and archiving process for the value streams in production, and general support across all value streams.  And furthermore, being responsible for conducting stability studies for products during material changes.

Major areas of accountability

• Document control in the documentation system (overall support) as well as archiving the process of documentation for value streams in production
• Supporting non-conformities related to documentation process
• Supporting and training in good documentation practice (GDP), and ensuring that the knowledge is distributed to all employees (production and non-production) on site
• Qualification of stability study chambers/rooms in accordance with local and global requirements
• Creating and handling stability studies (protocol, reporting) and being one point of contact with global function
• Participation and facilitation in Root Cause Analysis sessions
• Creation of Certificates (of compliance/analysis) for finished good production, and ensuring these are distributed to the markets
• Involved and supporting in external and internal audits
• Analyses and maintains processes and procedures to ensure compliance, effectiveness, and improvements to the quality system (including updating relevant procedures)

Reponsible for:

• Performing their job in compliance with the guidelines given
• Drawing attention to the manager to any difficulties in understanding or following the guidelines
• Drawing attention to inefficiency of the system
• Take responsibility for those safety aspects identified for the given position
• Support the positive EHS culture

Essential qualifications

• High School Diploma Completed
• Technical degree within Quality or Productivity
• Minimum 1-3 years of experience within medical device manufacturing
• A2 english level
• Knowledge with work in Microsoft Office 365 (Word, Excel, PowerPoint)

Prefer qualifications

• Analytical and problem-solving skills
• English level A2+
• Experience in medical industry

Required knowledge, skills & abilities

• Ability to effectively interact with various internal and external customers/ vendors
• Ability to read, analyze, interpret, and implement department procedures
• Must work well independently and be adaptable/flexible with team members
• Attention to detail and ability to follow up on previous work
• Must lead by example and demonstrate professionalism
• Must set and follow through with behavioral expectations
• Must pass skill and knowledge onto other team members