BD (Becton, Dickinson and Company) Quality Manager in New Jersey

Job ID: 2018-11066

Career Level: management

Division: Delran

Relocation: No

Location: Delran,New Jersey,United States

Summary of Position with General Responsibilities:

Responsible for the general management of the Delran Operations Quality Assurance function to assure compliance to established standards of corporate objectives and regulated agencies for industry (ISO and FDA). Responsible for the planning, development, and implementation of quality systems that support the Delran Ops and Davol business objectives. Appointed as FDA/ISO management representative for the site.

Essential job Functions:

  • Support the facility as a Quality Management System (QMS) Representative.

  • Development, implementation, and maintenance of quality systems to assure FDA, and ISO compliance.

  • Provide leadership in the implementation and execution of Quality Systems activities execution of the programs and processes related to CAPA, Management Reviews, Supplier Quality Management, (Scars and Inspection) Management Reviews, Non Conforming and internal audits and training activities, validations etc.

  • Optimize quality systems to effectively identify measure and reduce cost of quality activities, where applicable.

  • Identify, support, and develop departmental resources to achieve business and quality objectives.

  • Coordinate all facility audits (FDA, ISO, Corporate, Customer).

  • Review and approve Engineering changes to product; processes and materials.

  • To promote and support multi-discipline teamwork, i.e., activities that support the Delran management system inclusive of Davol and Bard Puerto Rico strategic initiatives and tactical plans.

  • Coordinate management review periodically to assess the effectiveness and suitability of the quality management system.

  • Supervises Quality Engineering, and QC Inspectors in support for incoming, in-process and final inspection and batch record product release.

  • Applies problem-solving skills to the corrective and preventative action (CAPA) process to eliminate problem root cause(s).

  • Develops strong partnering relationships with Engineering, Technology, Suppliers and the R&D community

  • Performs other duties assigned by his supervisor.

Basic Qualifications:

  • Working knowledge of US FDA and International regulations governing the medical device industry (i.e. QSR, GMP, MDR, and ISO 13485

  • Knowledge of fundamental quality systems principles such as CAPA, Failure Investigation and Management Reviews

  • Textile manufacturing experience is a plus.

  • Leadership, supervisory and development skills

  • Excellent interpersonal skills including the ability to interface and communicate effectively at all levels, both inside and outside the organization

  • Demonstrated ability to plan and manage multiple projects, including the ability to manage the resolution of technical and tactical issues

  • Demonstrated ability to understand, apply and analyze statistical controls, process validation and controls, and Inspection and Testing Methods validations

  • Must have good communication skills both, oral and written - bilingual (English/Spanish) and plus.

  • Team work oriented

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