Quality Manager
Freudenberg Medical
Alajuela, Costa Rica
hace 3 días

You support our team as

Responsibilitiesarrow right

  • Lead, Maintenance & Integration of the Quality Management System with all FMCR processes in accordance with the requirements of ISO 13485, MDD 93 / 42 / EEC, MDR 2017 / 745 & the FDA QSR 21 CFR Part 820.
  • Designated Management Representative & Executive Officer for Notified Body & Customer Audits. Management Representative has the responsibility and authority for the following :
  • Reporting to FMCR management on the performance of the Quality Management System and the need for improvement.
  • Promotion of awareness of regulatory and customer requirements.
  • Lead the Quality Assurance Function : Departmental liaison to ensure that products manufactured meet Customer & Regulatory requirements.
  • Ensuring that new product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, FDA - 21CFR Part 820, MDD 93 / 42 / EEC & MDR 2017 / 745 when appropriate.
  • Lead the Customer Complaint investigation process, MDD93 / 42 / EEC & MDR 2017 / 745 vigilance (Medical Device Reporting requirements and product recalls where necessary.
  • Lead the Plant Corrective & Preventive action program.
  • Participation & Maintenance of plant continuous process improvement programs.
  • Lead the Internal & External Audit Program(s) including quality system & product requirements are included in the plant Training Program(s).
  • Final Disposition of Non-conforming product including control of re-work & MRB co-ordination.
  • Training QC employees in procedures and good manufacturing practices.
  • Support the Data Protection Compliance Officer and champion compliance with data protection legislation. Ensure all processes, systems and employees within area of responsibility are operating compliantly and within the requirements of the GDPR and its principles.
  • Responsible for certification and validation of controlled areas (Clean rooms). Responsible to maintain the CER areas operative, over the specification’s values according to validation and the daily monitoring parameters.
  • Responsible for metrics tracking and performance related to the quality system as : Company KPIs, scrap rate, scrap cost, PPM, CAPA incidence, QN statistics, etc.
  • Ensuring compliance with budgets and plans.

    Qualificationsarrow right

  • B.S. Degree in Engineering or Master’s degree.
  • Six Sigma Black Belt Certification.
  • 7 years of Quality, Manufacturing, and / or Product Development, experience.
  • 5 years minimum of medical device experience.
  • 5+ years of experience in demonstrated ability to manage, coach and mentor employees.
  • Excellent English Skills working with teams in the USA.
  • Experience in a metric driven culture.
  • Previous experience participating in or leading a Quality audit or section of an audit.
  • ISO Quality Systems requirements, FDA GMP, and QSR.
  • Electronic Quality Management System.
  • Able to review and analyze data and documentation.
  • Effective and competent management, leadership, and organizational skills required and valued as part of the leadership team.
  • Good reasoning abilities and sound judgment.
  • Ability to communicate effectively (written & spoken) as required for job related communication throughout the organization.
  • Trustworthy, discrete and a high degree of personal integrity to maintain sensitive and confidential information.
  • Accurate and attentive to detail.
  • Excellent communication and presentation abilities.
  • Ability to lead and support others.
  • Ability to read and interpret documents.
  • Ability to travel as needed (10 - 20%).
  • Ability to manage customers and have to crucial conversations.
  • Local Candidates in Costa Rica ONLY
  • Your Benefitsarrow right

    Performance-related bonus

    Performance-related bonus : When you have an impact, you can reap the rewards

    Diversity & Inclusion

    Diversity & Inclusion : Enter a diversity-driven world of innovation

    Car allowance

    Car allowance : A monthly allowance to buy / lease, maintain a personal vehicle

    Sustainability / Community service

    Sustainability / Community service : Making a difference with sustainability, community service

    Occupational safety

    Occupational safety : Safety as a top priority, in all aspects of your work Local Candidates in Costa Rica ONLY The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion.

    Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. autorenew

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