Associate Director Quality Systems

4 weeks ago

Covington, United States BD Full time

Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Provides strategy for Quality Systems, to include Document Control, Training, Internal Audits, Compliance, and CAPA.

Creates, reviews, and approves Quality System Documents.

Develops staff by ensuring the selection, orientation, development, and retention of a sufficient number of qualified staff to fulfill the responsibilities of the department.

Responsible to maintain the UCC change controls process through use of BD EDMS (Electronic Document Management Systems) to ensure control of associated documentation and records.

Responsible to deploy UCC training program structure, using BD electronic training system, to allocate UCC QMS specific training profiles, and ensure evidence of training completion for employees.

Analyzes audit non-conformances and implement comprehensive & systemic corrective and preventive action plans.

Performs Internal Quality System Audits, where applicable and ensures trained staffing for internal audits is available for the UCC network.

Ensures compliance to policies and procedures.

Tracks and trends Quality Indicators as defined by local, business unit, or corporate policies.

Completes required business unit metric reporting to corporate.

Interfaces with UCC manufacturing facilities.

Interprets corporate policies and regulations as to how they relate to prepare and implement business unit procedures for conformance in the areas of responsibility.

Provides leadership for the overall CAPA process, ensures the functioning of the CAPA Board, and that overall system performance meets procedural expectations.

Analyzes internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards, and corporate policies and procedures.

Reviews Corporate Quality Audit Reports and prepares appropriate corrective action responses.

Develops team goals and ensures that quality plans are aligned with business objectives and meet regulations.

Participate and have membership in trade and/or professional organizations.

QUALIFICATIONS:

To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required.

Ability to independently perform work of a broad nature.

Extensive knowledge of medical device regulations including FDA 820, ISO 13485, applicable industry, or international standards, including the ability to interpret and implement on behalf of the UCC QMS

Ability to understand Corporate, Business Unit, and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.

Ability to interface with regulatory bodies to present technical information and demonstrate UCC compliance.

Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies.

Ability to serve in leadership capacity on projects or assignments.

Comprehensive understanding of auditing principles and ability to perform as a lead auditor.

Ability to participate and provide leadership on teams and maintain positive work environment with those teams.

Broad knowledge of medical device manufacturing processes.

Excellent communication skills (verbal, written, and presentation). Understands how to present information to varying levels within the organization.

Ability to effectively manage time and resources.

Ability to manage multiple project assignments.

Comprehensive knowledge of quality systems and relationship to business.

Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understanding of team functions, leadership techniques and project management methodologies.

Other duties and projects as assigned.

EDUCATION and/or EXPERIENCE :

Minimum four (4) year B.S. in Engineering, Science, or Mathematics degree or equivalent experience. Advanced degree in Engineering, Science, Business or other equivalent technical field is preferred.

Minimum ten (10) year’s experience in a decision-making position as a Quality professional or equivalent quality related experience with at least five (5) year’s experience in medical device or pharmaceutical Quality systems; preferable to be inclusive of specific experience with CAPA, Internal Audit, or Documentation management or other Quality Management System elements.

American Society of Quality (ASQ) Certified Quality Engineer, or Certified Quality Manager, or Certified Quality Auditor preferred.

Direct experience with FDA QSR and ISO 13485 compliance.

LANGUAGE SKILLS:

English required.

WORK ENVIRONMENT:

This position is hybrid role, with expected 3-day on-site office work per BD guidelines. The physical demands as required to perform the essential functions of this job are those of a basic office environment and ability to travel as needed.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Office environment

Manufacturing environments

TRAVEL:

This position may require some travel (

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