Quality Assurance & Regulatory Specialist
Olympus Medical Products Portugal (OMPP)
Coimbra
há 5 dias

Olympus Medical Products Portugal is a subsidiary of the Olympus Group. Its core business is the repair of optical and digital equipment’s of the brand, offering to Olympus customers repair services that meet highest demands in terms of speed, approachability, reliability and consistency.

Your responsibilities

Maintenance and proactive development of the quality management system within OMPP including necessary preconditions like certifications of the quality management system in order to ensure compliance with applicable laws and regulations.

Support and implement the necessary Compliance activates.

Your main responsibilities :

  • Maintain and develop the quality management system and its documentation to be in compliance with regulatory requirements
  • Create and maintain quality system records
  • Plan and conduct employee Quality Management training for employees
  • Conduct and support quality audits
  • Carry out and administer quality system processes, e.g. CAPA, change control
  • Support relevant quality metrics and KPIs of Quality
  • Provide support for QM & Compliance Department in document change control and coordination of the revision, review, and approval of necessary documents.
  • Processing of compliance incidents and implementation of any improvement measures.
  • Monitor the compliance within the requirements of ISO 13485 standard.
  • Maintain and implement changes of the Compliance area (e.g. development and optimization of guidelines, processes, and internal controls).
  • Foster and promote a culture of Quality and Compliance
  • Your qualification

    Minimum of 3 years of experience working in Quality Management (Industry or Quality Area with focus on quality / audit management or professional experience in this field).

    Specific skills :

  • Understanding of the regulatory requirements
  • English Intermediate
  • NP EN ISO 9001 (preferential)
  • NP EN ISO 13485 (preferential)
  • Familiar using database program for documentation control / contracts
  • IT knowhow (SAP, Microsoft 365)
  • Soft skills :
  • Accuracy
  • Accuracy
  • Well organized
  • Ability to work with multitask and priorities
  • Interpersonal skills
  • Effective problem-solving skills
  • Familiar using database programs
  • Ability to work as part of a team
  • Can motivate themselves to organize and plan their workload
  • Clear & concise written and spoken communication skills
  • Ability to present information in a structured way of varied technical levels
  • Attractive salary

    Permanent employment contract

    Work in a multicultural and diverse environment

    Referral commission

    Medical Health Insurance

    Initial and continuous training

    24 vacation days off

    Day off on your birthday

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