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Danaher Corporation Manager, Quality Systems and Regulatory compliance in Solna, Sweden

Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In our facilities in Solna / Sundbyberg we develop and manufacture diagnostics tests that improve patient outcome all over the worldPOSITION SUMMARY:

The Manager will Manage Quality Systems (QS) processes and related deliverables in conjunction with Company objectives and Regulatory requirements. Mentors and provides ongoing teaching, guidance and assistance of process owners, CAPA stakeholders, internal auditors, managers and their team to ensure awareness of regulatory requirements.

Interact with global QS counterparts in the headquarter to ensure a good alignment of QS processes

ESSENTIAL JOB RESPONSIBILITIES:

  • Lead and monitor Solna site audits and Quality system inspections readiness

  • Lead and develop Cepheid Quality System team ensuring Cepheid AB has continuous compliance with the corporate Quality Policies and applicable regulatory requirements

  • Lead the Quality System team to ensure compliant and timely deliverables, such as internal audit program, Quality training program for Solna site, CAPAs, Corrections, etc…

  • Participate to the definition of annual quality goals and quality plans

  • Lead the 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.

  • Provide guidance and trainings in multiple Quality and Regulatory related disciplines to cross-functional groups

  • Promote and develop standardization and simplification of QS documentation, and facilitate continuous QS process improvement

  • Develop tools for the efficient monitoring of QS deliverables (use of visual and daily management)

  • Control and approve QS document changes

MINIMUM REQUIREMENTS:

Education or Experience (in years):

  • At least five years experience in Quality Assurance, in the diagnostics / medical device industry

  • Excellent skills in written and verbally (English required)

Knowledge and skills:

  • Qualified Quality System auditor (ISO9001 – ISO13485)

  • Knowledge of risk management standard (ISO14971) and tools (FMEA, FTA etc..)

  • ISO 13485, 21CFR Part820, MDSAP related regulations

  • Experience or capacity to lead and develop associates

Physical requirements/abilities:

  • N/A

Other:

  • High adaptability and flexibility

  • Multi-tasking ability

  • Strong leadership and excellent communication skills

  • Ability to prioritize, sense of urgency

  • Can provide clear objectives and support associates for their achievement

  • Careful and thorough

PREFERRED REQUIREMENTS (optional):

  • Experience of international multi-site company

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

Operating Company: Cepheid

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