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Validation Manager H/F - CDI (24)

Location: 

Sarlat la Caneda, FR

Job Family:  Quality Assurance
Country/Region:  France

Validation Manager H/F - CDI (24) 

Job summary

Lead the Process Validation activity to ensure CMF comply to the regulatory requirement of MDR and to Coloplast Guidelines.

The validation activity includes:

  • The process risk management;
  • The production process validation;
  • The production and quality system software validation

 

Develop 6 Sigma mindset and deploy SPC to support production activity

 

Missions

 

  • Responsible for Equipment qualification and production process validation
  • Define Validation Master Schedules and update as needed
  • Write/verify equipment qualification and process validation protocols
  • Organize, supervise and/or participate to execution of qualification/validation tests
  • Manage any non-compliant equipment and associated deviations
  • Carry out and/or participate in FMEA processes
  • Implement the statistical techniques necessary for data analysis
  • Participate in the training of other departments on new processes/equipment as well as the Qualification / Validation process
  • Evaluate the impact of change files on qualification and validation files
  • Manage one Validation technician

 

Job qualifications

  • Engineer or equivalent
  • Experienced in Process validation / Software validation / Medical devices industry
  • Experienced in team management

Competencies

  • In-depth knowledge of the regulations and standards associated with medical devices and process validation methodologies and computerized systems (ISO13485, 21 CFR 820, ISO19227, ISO11607-1 and -2, ISO 17665-1 to -3, ISO 11137-1 to 3, 21 CFR Part 11...)
  • PC skills applied to validation
  • Process validation skills
  • Software validation skills
  • Lean 6 Sigma skills
  • High Analysis skills
  • English spoken and written
  • Good interpersonal skills
  • Strong Team management skils

 

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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