QA/ra Manager

hace 4 días

Barcelona, España Page Personnel España A tiempo completo

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.

QARA Manager.|Pharma Company (Vallés Or.).
- 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.

Leader Pharma Company.
- Permanent Contract.
- Competitive Salary.
- 3 days a week working from home.
- Flexible Schedule.
- Multicultural and friendly team.
- Exciting opportunities for professional development.
- Ongoing training.
- Multiple Social benefits: Canteen, health insurance, nursery check, English training...

The role is responsible to support and facilitate the Regulatory Affairs activities to ensure that products comply and meet medical device regulatory requirements.

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

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