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Quality Manager

  • Job reference: 924739
  • Location: Cork City, Cork
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 08/04/2019

Orion Group are recruiting for a Quality Manager on a permanent basis on behalf of our Multinational Medical Device Client based in the East Cork Area.

Department: QA

Reports To: Snr. Director QA/RA Europe & Asia

Job Summary:

The Quality Manger will be responsible for leading and managing a Quality Team in supporting site day to day operations. He / She will promote an awareness of Quality Assurance throughout the business and ensure Quality Systems are maintained and developed in line with the site Quality Plan and Global Symmetry objectives.

Job Responsibilities:

  • Liaise with and support all functions in managing Customer requirements and Change initiatives
  • Providing Manufacturing Support and leadership to QA and Engineering teams, applying practical problem solving techniques as required.
  • Provide Leadership regarding Continuous Process Improvement of the QMS and Operational Processes, with a Quality and risk management perspective
  • Manage all External Audits (Customer and Regulatory agencies) ensuring all QMS requirements per FDA Part 820 and ISO 13485 are robust and compliant.
  • Maintain a culture of compliance to QMS systems throughout the organisation including:-

A compliant and timely NC / CAPA system, Change Control system, Auditing system, Validation system, Supplier Management, Records Management, DHR and DMR systems

  • Ensure appropriate Risk Management systems are applied with regard to NC and Change Management.
  • Ensure best practice Processes and Equipment Validation is conducted at all times.

Skills, Abilities and Education

  • A bachelor's degree in engineering or a related field and/or a combination of practical and educational experience in the medical device industry is required.
  • The ideal candidate will have worked and thrived in the current medical device industry with the majority of their experience gained during the last 5 years. The ability to complete the tasks above on his/her own initiative is paramount. Superior communication skills are essential to deal with a growing and diverse workforce and customer base.
  • Experience in managing a team of resources.
  • Experience Leading External Audits by Regulatory Bodies
  • Experience in leading FDA audit preparation and management
  • Have thorough working knowledge and comprehensive understanding of ISO13485:2003 and 21 CFR Part 820
  • Possess the drive and ability to drive systems and compliance throughout the organization

Intent and function of job description:

Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all inclusive.

Job descriptions are not intended as and do not create employment contracts. This organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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