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QA Development Manager H/F - CDI (24)

Location: 

Sarlat la Caneda, FR

Job Family:  Quality Assurance
Country/Region:  France
 

This position manages the supplier quality, and design assurance teams – ensuring compliance with applicable regulations and corporate requirements, and driving quality deliverables. This leader will be responsible for leading, maintaining, and developing the organization inline with the growth of the Interventional Urology business unit based in Sarlat.

 

 

Missions :  

 

  • Management
    • Lead and the develop the design assurance teams and supplier quality
    • Align and partner with multiple sites and corporate (global)
    • Participate to CAPAs and NCRs management, or participate to corresponding action plans
    • Participate in material changes comittee, risk management activities
    • Review and approve technical documentation
    • Promote continuous improvement through identifying and implementing improvements to supplier controls, product design and quality systems
    • Participate in quarterly management review meetings
    • Drive internal or supplier audits

 

  • Design Assurance
    • Execute quality owned design deliverables necessary to sustain commercialized product and launch new products
    • Focus includes test method validation and ensuring applicable design standards are addressed
    • Lead transfer reviews
    • Evaluate conformity of documentation to be implemented in production (DMR)
    • Manage and carry out products ageing stability tests and transportations studies (writing of the file and tests)
    • Manage sub-contracted transport tests

 

  • Supplier Quality
    • Oversee supplier related project resourcing, budgeting, project scheduling and communication
    • Oversee supplier quality including monitoring, scorecards, audits, quality agreements, SCAR's, validations, and material changes
    • Review and approved the Component and Raw Material specification (DSP) and the General Quality Agreement on behalf of the Head of Quality

 

 

 

Profil: 

 

  • Engineering degree or equivalent
  • QA (ISO13485, ISO9001, MDSAP, Règlement Européen)
  • Management experience
  • Mastery of Excel
  • English read, written and spoken

 

  • Confidentiality
  • Reactivity, rigor and excellent interpersonal skills are essential
  • Strong team spirit
  • Enthusiastic, communicative
  • Flexible to changes

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

 

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

 

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