QA/RA Manager - Pharma Company (Vallés Or.)

Cooperating with the QA/RA Director to co-ordinate quality assurance activites.
Mantaining Quality Management system procedures.
Cooperating with different company departments for implementing quality system procedures.
Supporting internal and external Quality System audits.
Supervising software development process assessments.
Monitoring and advising on how the quality system is performing.
Ensuring and providing quality system training to all employees.
Cooperating with Corrective and Preventive actions management.
Coordinating Certification Entity, Notified Body and/or Competent Authorities interactions.
Cooperating in post-market surveillance activities and complaints management.Minimum of 5 years of work experience in a Quality department, preferably within the Healthcare sector.
Experience scheduling and performing internal audits and CAPAs management.
Experience reviewing technical documentation and reports.
Extensive knowledge of software medical device regulations and standards (ISO 13485, ISO 14971, ISO 62304).
Reviewing standard operating procedures and work instructions.
Able to detect improvement actions.
Fluency english.
Leadership skills to create an environment where the QA team work together to deliver outstanding results.
Communication skills with the ability to interact effectively with all levels of management.

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