Duties and Responsibilities
- Possesses and applies a broad and increasing knowledge of Quality, and its application within Alere, to the completion of moderately complex assignments
- Broad knowledge of Alere’s organization’s operations and practices to enable informed decisions in day to day operations and assignments
- Applies problem-solving skills in order to deal creatively with complex situations work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve
- Demonstrates skill in data analysis techniques by resolving missing/ incomplete information
- Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances
- Drives business improvements through continuous improvement initiatives
- Escalation point for quality related non-conformances and CAPAs
- Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification
Minimum Qualifications & Skills
- Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
Education & Experience
- Third level qualification
- Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including; Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP) & Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
- Broad knowledge of engineering and technical applications applied in development of medical devices useful
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent