Quality Systems and Regulatory Compliance Manager
2 weeks ago
Cepheid is seeking a highly skilled Quality Systems and Regulatory Compliance Manager to join our team in Solna, Stockholm, Sweden. As a key member of our Quality Assurance department, you will be responsible for managing Quality Systems processes and related deliverables in conjunction with Company objectives and Regulatory requirements.
Key Responsibilities:- Lead and monitor Cepheid AB site audits and Quality system inspections readiness
- Develop and implement Quality System team strategies to ensure Cepheid AB has continuous compliance with corporate Quality Policies and applicable regulatory requirements
- Manage Quality System team to ensure compliant and timely deliverables, such as internal audit program, Quality training program for Cepheid AB, CAPAs, Corrections, etc...
- Participate in the definition of annual quality goals and quality plans
- Lead Quality System Management reviews
- Monitor Quality key performance indicators and coordinate Problem Solving Plan cross-functional teams where needed
- Manage CAPA process and ensure compliant and timely deliverables of corrective and preventive actions
- University degree in Life Science or related
- At least five years experience in Quality Assurance, preferably in the diagnostics / medical device industry
- Excellent skills in written and verbally (English required)
- Experience of external audits and of working in a global environment
- Experience or capacity to leading projects or teams
- Qualified Quality System auditor (ISO9001 – ISO13485)
- Knowledge of risk management standard (ISO14971) and tools (FMEA, FTA etc..)
- ISO 13485, 21CFR Part820, MDSAP related regulations
Cepheid, a Danaher operating company, offers a comprehensive benefits package that includes health care programs, paid time off, and career growth opportunities. We value diversity and the existence of similarities and differences found in our workforce, workplace, and throughout the markets we serve. Our associates, customers, and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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Solna Municipality, Sweden Cepheid Full timeAbout the RoleCepheid is a leading provider of diagnostic solutions, and we're seeking a highly skilled Quality Systems and Regulatory Compliance Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for managing Quality Systems processes and related deliverables in conjunction with Company objectives and...
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