Job Description Summary

The Director, Quality Management Systems establishes, directs and ensures that all change management, document control, training, compliance, complaint management, internal audit, CAPA and management reporting activities are in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations and BD policies and procedures that apply to devices manufactured by or for the Surgery Business Unit. Additionally, the Director, Quality Management Systems functions as a subject-matter expert for document control, change control, training, internal audits, Notified Body assessments, FDA audits, adverse event reporting, post-market surveillance, and quality systems compliance. This position is key in developing the compliance strategy for Surgery and represents Surgery in the Segment and BD Corporate initiatives.

Job Description

Functions Directed

This position has an organization of indirect and direct reports, including permanent associates, temporary workers and consultants located at multiple sites.

• Surgery Business Unit Functions – the following functions are traditional to Quality Management Systems leadership role:
  • Quality Systems – Directs the Surgery-wide strategy for the Quality Management System in compliance with regulations and standards around the world.  Ensures process owners are defined and coordinates continuous improvement in QMS procedures and work instructions.  Leads and supports projects to integrate Surgery and BD QMS policies, procedures and practices based on coordinated BD Integration Program plans and schedules.  Conducts required Management Reviews of key quality and performance data to ensure the quality system is adequate and effective.
  • Document Control - Directs the Surgery-wide document control activities to ensure all applicable documents are controlled and revision histories maintained.  Serves as business owner for the EDMS.
  • CAPA - Directs the Surgery-wide activities to ensure corrective and preventive action is appropriately applied to ensure products and processes address key issues and process improvements.  Reviews and approves CAPA investigations, root cause analyses, corrections, corrective actions, preventive actions and any necessary schedule extensions. Serves as business owner for the TrackWise electronic system.
  • Situation Analysis/Field Actions - Directs the activities to ensure adequate documentation for the assessment of field issues or conditions that must be considered for field action/recall decisions, escalates those decisions to the Segment level when required and ensures the implemention the field action execution when required.
  • Complaint Handling - Directs the Surgery-wide complaint activities to ensure regulatory requirements are fulfilled for complaint intake, complaint investigation, analysis of returned product to confirm complaints and determine root causes, coordinating manufacturing DHR reviews and ensures required MDR/Vigilance reporting.  Serves as business owner for the TrackWise complaint handling electronic system.
  • Post Market Surveillance - Directs the activities to comply with regulatory requirements for post-market surveillance of Surgery products on the required schedule for adequacy of product instructions for use, risk management, clinical performance and other key factors.
  • Compliance and Internal Audit - Directs the activities for conducting internal audits across the Business Unit and manages all external audits by Notified Bodies, FDA and other Competent Authorities world-wide.
  • Analytics - Directs the activities to ensure adequate trend analysis and statistical monitoring of complaints, supplier data, manufacturing data and other key reports for regulatory requirements and Surgery leadership visibility.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

• Represents the Corporation, Business Unit and Quality Department in a professional manner.
• Provides strategy for Quality Systems, to include document control, training, internal audits, compliance, complaint management, CAPA, post market surveillance, and continuous improvements.
• Creates, reviews and approves Quality System Documents.
• Analyzes audit non-conformances and implements comprehensive & systemic corrective and preventive action plans.
• Ensures compliance to Business Unit, Segment and applicable Corporate procedures.
• Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards / changes are incorporated into Business Unit strategy.
• Tracks and trends Quality Indicators.
• Ensure post-market surveillance activities are scheduled and executed on time to support continue commercialization of Surgery products.
• Interfaces with Surgery manufacturing facilities as well as other Segment and Corporate functions.
• Establish the systems and processes for receiving, handling, investingating complaints including the assessment tools for determining and reporting MDRs.
• Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities.
• Executes on Quality Key Driver Goals as approved by the Surgery Leadership Team.
• When required, respond to interrogatories, collection of documents and participate in depositions.
• Ensures maintenance all required records for the QMS.
• Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department. 
• Provides leadership for the overall CAPA process and all non-product CAPAs.
• Analyzes internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards, Corporate quality standards, and Business Unit and Facility quality standards.
• Develops, reviews and maintains Quality Policies for the Business Unit.
• Reviews Corporate Quality audit reports and prepares appropriate corrective action responses.

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, industry or international standards and ability to interpret and implement. 
• 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 at the Business Unit & Plant levels.
• Ability to interface with regulatory bodies to defend Surgery compliance.

• Understands basic applied statistics, statistical sampling plans, and statistical process control.
• 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.  Understands team functions, leadership techniques and project management methodologies.
• 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 handle multiple project assignments.

EDUCATION and/or EXPERIENCE

• B.S. Engineering or equivalent experience, advanced degree is preferred.
• American Society of Quality (ASQ) certifications (CQE, CQA, CMQ/OE, etc.) preferred.
• Minimum 20 years of experience with FDA regulated industry including experience with warning letters and other regulatory actions.
• Minimum 10 years of managing a professional staff, including managers and supervisors.

LANGUAGE SKILLS

• Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to read, analyze, interpret and present business data and results.
• Ability to write reports, business correspondence, and procedures.
• Ability to effectively present information and respond to questions from varying levels and functions of the organization.
• Well versed in English language skills, both verbal and written.

MATHEMATICAL SKILLS

Well versed in statistics, analytical reasoning skills based on data.

REASONING ABILITY

• Highly variable operations performed daily from complex regulatory and engineering decisions to routing administrative functions. Interpretation of regulations into standards and procedures as required.  The ability to explain these interpretations to Plant, Business Unit, Corporate and representatives of Regulatory bodies is necessary.
• Individual is looked upon as a decision-maker, one of high integrity and decision-making skills.  Decisions made by this person could have significant regulatory and financial implications. 
• A great deal of self-directed work must be initiated through a detailed knowledge and understanding of Surgery products and processes.  There is a great deal of freedom of action, originality and imaginative drive and critical analysis since there is not strict day-to-day supervision.  The success of implementation of quality plans is largely dependent upon the person’s ability to recognize the most efficient, cost effective and strategic approach to attaining the desired goal.  In many instances, the person will be required to use creativity and imagination in carrying out the job function.  This person will be working in a fast-paced, technically challenging environment where drive is critical to success.

WORK ENVIRONMENT

This position works in a normal office environment. Remote locations will be considered.

Travel may be required at 20%.

Primary Work Location

USA RI - Warwick

Additional Locations

Work Shift