BD (Becton, Dickinson and Company) Quality Manager, Quality Systems in Holdrege, Nebraska
Job Description SummaryThe Quality Manager, Quality Systems, defines business process and drives associated integration across all functions within BD-Holdrege to deliver the Quality System strategy . Critical to success include : the establishment of a documented quality systems , that assurances safe and effective medical products that satisfy internal/external compliance regulations and proposes/approved guidelines; collaborative with Quality Engineering Leadership; collaborative work with the Internal business.
Leads the Quality Systems, CAPA, Documentation, Training, Internal Audits.
Works with Regulatory agencies ( FDA, ISO notified body)
Evaluates , designs, implements and continually improves the quality system strategy, quality systems and process to achieve quality goal and to maintain a high level of quality systems compliance.
Chairing the Management review process,
Ensures compliance with local, state , federal and Corporate quality regulation, polices and procedures.
Evaluates adherence to Good Manufacturing Practices: worldwide regulations and guidelines.
Manages and performs quality systems audits.
Participates in continues improvement activities
Provides effective leadership in team work development, effective communication and quick responses to Customers.
Required skills/ knowledge
8+ years Medical Devices manufacturing experience
Demonstrated ability to lead direct ad influence people.
Excellent knowledge of the Quality System/ Quality Management
Knowledge of regulatory requirements as ISO 13485, EMDD, Canadian Medical device Regulation, 21 CFR 820 and 21 CFR 210
Strong understanding of Validation process and Six Sigma principles.
Problem solving problems
BS or BA degree
Advanced degree in the Science, Business or related field preferred.
Primary Work LocationUSA NE - Holdrege
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status