QA Engineer

Location Groningen, Gemeente Groningen, Groningen
Discipline: Medical Device
Job type: Temporary/Freelance
Contact name: Oliver Holding Fay

Contact email: o.fay@panda-int.com
Job ref: 13720
Published: 19 days ago

For a leading medical device company, I am looking for a QA Engineer to track and coordinate completion of production related nonconformances.

RESPONSIBILITIES

  • Ensure quality assurance within product and process development projects Perform and assess statistical analyzes and support the implementation of statistical process control techniques, sampling schemes and other quality techniques
  • Assess and (jointly) determine specifications for raw and auxiliary materials, processes, semi-finished products and end products in relation to internal and external quality standards
  • (Co-)supervising external (including DEKRA/FDA) and internal audits (CQA)
  • Drafting and reviewing protocols and reports
  • Non-conformity management
  • Advising, reviewing and (approving) changes in products/processes or systems, in line with the applicable procedures. Approving all QMS related procedures and work instructions
  • Compile and report metrics
  • Provide input to the Site Management Review
  • Continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven inputs.
  • Ensuring quality assurance within product and process development projects

- performing risk analyses

- drawing up the risk management plan and report

- drawing up validation plans and reports

- auditing the Design History File

- participate during Design Reviews

  • Ensuring quality assurance within technology developments
  • Perform and assess statistical analyzes and support the implementation of statistical process control techniques, sampling schemes and other quality techniques
  • Assess and (jointly) determine specifications for raw and auxiliary materials, processes, semi-finished products and end products in relation to internal and external quality standards
  • Review all changes to product specifications
  • Management of the quality system
  • Franchise procedures and regulatory standards roll-out,
  • Metrics reporting
  • (Co-)supervising external (including DEKRA/FDA) and internal audits (CQA)
  • Addressing non-conformities within production and taking care of internal escalations
  • Guiding planned deviations from the production process
  • Advising, reviewing and (approving) changes in production processes, in line with the applicable procedures
  • Analyzing data on rejects within the production process for continuous improvement and reducing or eliminating sources of variation within the production process
  • Ensure the preparation and implementation of the complaint handling process. 
  • Reviewing and approving prepared complaints reports
  • Support in executive work with regard to complaints handling where necessary
  • Identifying and communicating to management of bottlenecks with regard to complaints handling; adjusting planning regarding complaints handling where necessary
  • Analyzing and monitoring trends in complaints, with which a possible structural deviation can be identified and corrected. Reporting trends to stakeholders.
  • Ensure the execution of activities related to Manufacturing Systems Development Life Cycle (SDLC) and systems compliance according to applicable regulations and procedures
  • Provide support regarding the qualification of computerized systems ensuring that the validation approach, output and documentation comply with applicable procedures.
  • Granting permission for final release of the applications
  • Review / approve changes that require CSV approval to keep the CSV application in a validated state throughout its lifecycle.
  • Conduct independent reviews of CSV related validation documentation


PROFILE

  • Higher vocational education (preferably in the subject of technology)
  • Some years of relevant work experience, preferably in the pharmaceutical or medical-device industry 

Specific knowledge

  • Knowledge of relevant GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971
  • Knowledge of quality-assurance systems (QMS)
  • Knowledge of relevant work instructions and procedures
  • Knowledge of MS Office
  • Knowledge of validation of technical systems and processes
  • Knowledge of statistics and quality-improvement methods
  • Demonstrated experience with documenting and resolving production nonconformances
  • Strong communication skills and project management
  • Flexibility and accuracy
  • Ability to work independently and as part of a team
  • Excellent command of the Dutch and English language

 

START DATE

  • ASAP
     

DURATION

  • 6 months with a high chance of extension

 

LOCATION

  • Groningen

 

Interested?

If you are interested in the above description, apply with your CV

PS: Did you also know that we offer an attractive referral scheme?

For more information please contact Oliver Holding Fay on +31 (0)20 20 44 502 or o.fay@panda-int.com