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BD (Becton, Dickinson and Company) Manager, Quality Systems in San Diego, California

Job Description Summary

As directed by the Senior Quality Manager, this position is responsible for assuring quality standards and regulatory compliance are consistent with Corporate and Division Policies, Government Regulations, International Standards, supporting the continued development, improvement and implementation of the Quality Systems within BDB Biosciences Business Unit.

Job Description

Responsibilities :

  • Consistent application of Quality System standards (for example ISO 13485, ISO 9001, and 21CFR820). Work withing and across functions to ensure compliance to regulatory standards, company, and site policy and procedures.

  • Lead and support site’s CAPA – Effective use of DMAIC process to support CAPA process, detail technical review and approval of the CAPAs to ensure compliance to standard and effectiveness.

  • Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements

  • Develop applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies

  • Guides the successful completion of major programs and may function in a project leadership role.

  • Oversee site’s training program and Quality Management System, ensuring that the processes needed for QMS are effectively established, implemented, and maintained in accordance with standard and company’s policy and procedures.

  • Audit support - Act as lead auditor for internal audits within the site and cross site. Support external audits by customers and regulatory bodies (such as notified bodies and USDA).

  • Maintain trending and critical analysis of quantifiable measurement of emerging quality issues and provide recommendation for improvement. Recommend and initiate projects to resolve nonconforming issue(s), facilitate root cause analysis discussion using appropriate quality tools (for example Fishbone Diagram, 5-Whys), development corrective and preventative action

  • Manage and or support the risk management, quality system documentation, and validation and verification for new or change process.

Position-Specific Overview: Position specific responsibilities include support of the following, however, are not limited to :

  • Manage, coach, and mentor team. Ensure talent retention and performance management of team.

  • Maintains and improves the BDB San Diego Quality System.

  • Collaborates with cross functional partners to seek their input into the development of policies and procedures, Quality System manuals, and their support in addressing Quality Issues.

  • Facilitates cross-functional interaction and communication between Quality, Regulatory Affairs, R&D, Regulatory Affairs, Manufacturing, Operations, Sales, and Marketing and other applicable teams to support in Quality System improvement and compliance.

  • Participates and supports internal and external regulatory site visits, inspections, and audits. Including ensures that pre- and post-inspection activities are completed including scheduling, record review, training, logistics, etc.

  • Act as technical expert for regulations and standards including ISO 9001, ISO13485 & 21CFR820, requirements in support of site during external/internal audits and process harmonization.

  • Assists with NB, Corporate and other regulatory, external, and internal audit readiness, and processes harmonization globally.

  • Applies quality and/or standard-setting body requirements to develop solutions, control and/or maintain technical documents and/or Quality Systems.

  • Routine communication with Notified Bodies and plants; including possible consolidation of NB and / or certificates.

  • Trains, develops, and provides technical guidance to direct reports and other associates.

  • Actively participate in quality guidance and helps project & quality network teams for process improvement, standardization initiatives, and continuous improvement activities

  • Completes projects/other duties as assigned.

Requirements

  • Typically requires of 12 years relevant experience or a combination of equivalent education and relevant experience. Prior experience with managing external regulatory audit preferred.

  • Minimum of a B.S. in science, engineering, or other relevant discipline, with a minimum of five years relevant technical experience within medical, pharmaceutical or Life Science industry.

  • Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 9001, ISO 13485 requirements.

  • In-depth understanding of the application of quality systems to the medical device industry.

  • Industry recognized certification in a Quality System element specialty (e.g. ASQ Certified Quality Auditor, Quality Engineer) preferred.

  • Experience with Quality Management Systems, 12+ years (relevant experience or a combination of equivalent education and experience)

  • Experience in working directly with Notified Bodies and Regulatory Authorities.

  • Prior experience managing external regulatory audits preferred.

  • Excellent communication skills at all levels both written and verbal.

  • Ability to set and deliver to specific goals and targets.

  • Ability to perform multiple tasks and prioritize workload.

  • Effective analytical, technical, and problem-solving skills.

  • Effective meeting and presentation skills.

  • Effectively manage conflict.

  • Ability to work in or direct teams to obtain results.

  • Self-motivated /directed.

Certifications (if applicable)

  • Industry Recognized certification in a Quality System Element specialty (e.g., ASQ Certified Quality Auditor, Quality Manager, Quality Engineer, Six Sigma Green Belt) preferred

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, or any other protected status.

Primary Work Location

USA CA - San Diego (BDB)

Additional Locations

Work Shift

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, or any other protected status.

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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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