Skip Navigation

Sr. Quality Manager, Cybersecurity

Apply Now Job ID R-355111 Date posted 12/17/2019

Locations

Sparks, Maryland
Franklin Lakes, New Jersey
San Diego, California
San Jose, California
Louisville, Colorado

Job Description Summary

Reporting to the Associate Director of Corporate Quality, the Sr. Quality Manager leads cross-business and cross-functional network to implement new and emerging product security (cybersecurity) related regulatory requirements for medical devices in BD quality management system. In this role, the Sr. Quality Manager partners with the Product Security group to integrate product security/cybersecurity policy, procedures, and tools with the impacted processes of BD quality system such as design control, risk management and complaint incident response. Through the partnership with Product Security group, the Sr. Quality Manager provides coordination and alignment of Quality staff across BD businesses and functions with BD Product Security Policy and Procedure. The role also contributes to future definition of the Product Security Policies and Procedures across BD and any business unit specification while supporting tactics required to achieve Product Security objectives across business units and functions. Through outstanding communication; effective problem solving and active management of ambiguous situations; the Sr. Quality Manager helps BD to improve product security, product safety, product quality and compliance with all relevant global regulations and customer expectations. Success is measured in terms of the frequency and scale of product quality organizational issues as well as business process effectiveness. Through stakeholder engagement; and people development; the Sr. Quality Manager produces durable and industry leading results supporting key business drivers.

Job Description

Responsibilities:

  • Leading a cross-business and cross-functional quality network to implement new and emerging cybersecurity regulatory requirements in the quality management systems for all impacted business units.
  • Serving as the subject matter expert in product security/cybersecurity in the quality organization to provide strategic and tactical approach in implementing cybersecurity control and monitoring throughout the lifecycle of the impacted software medical devices.
  • Developing process and tools to integrate cybersecurity assessment and control in impacted quality processes such as design control, risk management and complaint handling.
  • Collaborating with Product Security group to receive technical information regarding current and future cybersecurity practices for integration into the BD Quality Management System.
  • Monitoring, measuring and improving the effectiveness of the implementation of product security/cybersecurity in individual business unit quality systems.
  • Supporting the development, implementation, and improvement of an effective quality system that meets appropriate WW Business, Division, Corporate, Government, and International Standards for security, efficacy, safety, quality, and customer satisfaction. Assures programs are consistent and in compliance with FDA Cybersecurity Guidelines, AAMI TIR57,  IEC 80001, and other medical device security standards in addition to FDA Quality System and Pharma type regulations, ISO 13485 and ISO 9000 (and similar) standards for IVD, Medical Device products in clinical, industrial and research applications as well as custom products designed for specific customers.
  • Ensuring alignment of the Product Security Office and compliance with associated policy and procedure.
  • Performing other related duties and assignments as required.

Qualifications:

  • A minimum of a bachelor’s degree required in Computer Science, Information Technology, or Engineering discipline.
  • A minimum of 3 years in implementing and/or applying cybersecurity control and remediation in a medical device quality management system.
  • A minimum of 3 years of practical experience in implementing and/or supporting Design Control, Risk Management, Complaint Handling and other elements of the quality system in a Medical Device or IVD industry.
  • A minimum of 2 years or practical experience with System Development Life Cycle (SDLC) for software medical device or IT systems.
  • Excellent analytical, technical, and problem solving skills (TQM or Six Sigma experience preferred).
  • Ability to influence without authority at different levels of the organization.
  • Excellent and experienced meeting and presentation skills.
  • Demonstrated ability to perform multiple tasks / large projects and to prioritize work load for function.
  • Effective in managing conflict and seeking effective solutions.
  • Knowledge and experience in financial management, planning, and organizational skills.
  • Self-motivated/directed.
  • PMP certification desired.
  • Professional certification is preferred (i.e. HCISPP, CSSLP, CISSP, Security+, RAC, CQA, CAE, SQE, CQM, Six Sigma, etc.)
  • Ability to travel 25% of the time both domestically and internationally.

#LI-OPS

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.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA CA - San Diego TC Bldg C&D, USA CA - San Jose, USA CA - San Jose (Reagents), USA CO - Louisville, USA MD - Baltimore

Work Shift

Apply Now

Similar Job Openings Nearby

Senior Manager, Software Quality Engineering San Diego, California 15369350
Sr. Engineer, Software Quality San Diego, California 15346227
Senior Quality Engineer Franklin Lakes, New Jersey 15334014
Staff Quality Auditor Sandy, Utah, Franklin Lakes, New Jersey, San Diego, California, San Jose, California, Covington, Georgia, Vernon Hills, Illinois, Sparks, Maryland, Research Triangle Park, North Carolina, El Paso, Texas 15334012

Join our Talent Community

Sign up to receive information about career opportunities, news and events.

Sign up

Join our Talent Community

Sign up to receive information about career opportunities, news and events.

Areas of InterestSearch for a category, location, or both, select a term from the suggestions, and click "Add".

  • Quality, Sparks, Maryland, United StatesRemove
  • Quality, Franklin Lakes, New Jersey, United StatesRemove
  • Quality, San Diego, California, United StatesRemove
  • Quality, San Jose, California, United StatesRemove
  • Quality, Louisville, Colorado, United StatesRemove

Find Your Role

Select a job category, location or group to view its corresponding jobs.

Jobs By Location

Jobs by Category + Location

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