BD (Becton, Dickinson and Company) Associate Director Quality Design Assurance in San Diego, California

Job Description Summary

Job Description

Summary

Reporting to the Infusion Director - Quality Management, The Associate Director Quality Design Assurance provides overall Quality leadership to Design and Development of key new product(s). Through outstanding communication; effective problem solving and active management of ambiguous situations; manager ensures product safety, product quality and compliance with all members of Core Teams and Program Management. Success is measured in terms of the frequency and scale of product quality and organizational issues as well as business process effectiveness. Through internal and external stakeholder engagement; and people development; the Associate Director Quality ensures projects produce high quality products, compliant project deliverables and efficient execution.

Primary Responsibilities

  • Manage Quality Engineers on multiple projects and/or subsystems of projects.

  • Ensure the team’s quality representatives are capable and resourced to fulfill their obligations and to comply with applicable regulations and procedures.

  • Ensure effective design transfer between development and manufacturing

  • Effectively partner with R&D to define deliverables and troubleshoot technical issues. Engage with (or may lead) quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision.

  • Mentor and develop personnel, including dedicated succession planning and contingency management.

  • Effectively navigate and lead through the challenges of change and establish global stakeholder engagement focused on win-win solutions.

  • Continuously evaluate progress toward objectives adapting them to meet customer and business needs.

  • Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by platform/business/function objectives.

  • Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.

  • Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors.

  • Perceived as thought leader possessing subject matter expert knowledge of design controls.

  • Build an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.

Scope

Policy and Strategy

  • Establishes and drives implementation of strategy and direction.

  • Ensures effective implementation for the assigned quality function in alignment with strategic plans established with top management and executive leadership. Contributes to business strategies and plans.

Sphere of Influence

  • Interacts both internally and externally with senior-level management, requiring negotiation of extremely critical matters. Influences decision making (e.g. via the PDT). Understands and works to improve effectiveness of the BD matrix.

Supervision

  • Directs and controls the activities of multiple Quality Engineering core team members.

Talent Management

  • Advances the global leadership bench strength of the company.

Impact of Decisions

  • Decisions and recommendations have a significant long-term impact on the unit and affect the financial, associate, or public relations position of BD.

Position Specific Overview

The Associate Director Quality position is responsible for: developing, assuring that the organizational structure, responsibilities, procedures, processes, and resources for the Design Control Quality Systems and implementation of Quality compliance are adequate to meet the needs of the WW business and conform to all applicable regulatory requirements, including all adopted industry standards and BD Corporate Quality and Regulatory Compliance Policies.

Responsible for the development, implementation, and improvement of an effective quality system that meets appropriate WW Business, Division, Corporate, Government, and International Standards for efficacy, safety, quality, and customer satisfaction. Assures programs are consistent and in compliance with FDA Quality System and Pharma type regulations, ISO 13485 and MDR (and similar) standards for Medical Devices.

Serves as Quality Program Leader for complex new product development projects. Ensures successful development, verification, validations and transfer of design. Monitor and influence key support functions that enable these goals including: Supplier Quality, Sourcing, Manufacturing Risk Management, etc.

  • Establishes and leads business and functional and strategies / objectives.

  • Considered an expert in their functional knowledge and expertise to the business. Participates in a wide variety of business discussions and decisions for the development of new products, manufacturing strategies, and sustaining / post market activities.

  • Must keep current with US and International regulations affecting product development, manufacturing and WW commercialization. Interprets and communicates changes to the business and project teams.

  • Carries out Management responsibilities such as the hiring, job assignments, performance planning and talent development, salary actions, performance reviews, and termination recommendations.

  • Perform other related duties and assignments as required.

  • Excellent analytical, technical, and problem solving skills (TQM or Six Sigma experience preferred).

  • Excellent and experienced meeting and presentation skills (presents at Trade Shows / Conferences).

  • Ability to perform multiple tasks / large projects and to prioritize work load for function.

  • Effectively / actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties

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

  • Knowledge and experience in financial management, planning, and organizational skills.

  • Self motivated/directed.

  • Excellent analytical, technical, and problem solving skills (TQM or Six Sigma experience preferred).

Qualifications

  • Requires a Bachelor's degree in Microbiology, Molecular, Cell Biology, scientific or engineering discipline. Individuals with an advanced degree preferred.

  • A minimum of 9 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.

  • A minimum of 5 years directly managing Quality professionals.

  • Professional certification is preferred (i.e., RAC, CQA, CAE, SQE, CQM, Six Sigma, etc.)

#LI-OPS

Primary Work LocationUSA CA - San Diego TC Bldg C&D

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