Job Description: Summary
The Associate Director, Quality establishes, directs and ensures that all capital equipment and disposables devices are in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations that apply and that capital equipment devices manufactured by BDUCC. The Director, Quality has the authority, responsibility, and accountability for all activities and associated documentation related to Capital Equipment, Disposables, and associate regulatory compliance.
Maintains and enhances BDUCC Capital Equipment compliance to ISO requirements and other international regulations.
Analyzes internal Quality Management Systems and associated data to assure adherence to QSRs, ISO, EU MDD, MDSAP, and other international standards, Corporate Quality standards, and Divisional and Facility Quality standards.
Develops, reviews and maintains Quality Policies for the Division's Capital Equipment and Disposables portfolio.
Lead New Product Development (NPD) Quality Engineering to support Quality system design and implementation for compliance with BDUCC procedures, regulations and international standards requirements.
Support product development by preparing Quality and Reliability plans, reviewing design plans and approving qualifications and validations. Support licenses and acquisitions by investigating levels of compliance, Quality and reliability of potential technologies and/or companies (due diligence).
Lead and provide support to Sustaining Engineering (SE) and continuous product improvement initiatives.
Integrates design and manufacturing process with Quality Engineering principles to assure sound scientific decisions.
Ensures adequate systems are in place to assure the integrity of designs as they evolve through the development process up to and including design transfer and post-market launch support.
Responsible for the investigation of product and process Quality and Manufacturing issues.
Coordinates complaint investigations and trend analysis, makes recommendations and reviews associated action plans for complaint reduction.
Keeps the Management Board informed about Quality-related problems and issues.
Travels to Division Operations Facilities and to supplier locations to carry out the duties described above.
Oversight and collaboration responsibilities for manufacturing Quality operations in Louisville CO, Zelienople, PA, and Nogales, MX and for depot service Quality operations in Zelienople, PA, and Crawley, UK.
Provides strategy for Quality Systems, to include Document Control, Training, Internal Audits and Compliance.
Analyzes audit non-conformances and implement comprehensive & systemic corrective and preventive action plans.
Responsible to assure that products are being designed, developed, manufactured and distributed under appropriate Quality Systems and controls that comply with corporate policies, Good Manufacturing Practices (GMPs), and other applicable requirements such as ISO 13485, state, and international regulations.
Acts in role of Management Representative for the facility.
Manage field actions including recalls and field notifications. Provide progress information for FDA reporting activities until recall is complete.
Host FDA, Notified Bodies, MDSAP, EU MDD, Corporate and internal audits. Responsible to assure the corrective actions to any audits are implemented in a timely fashion.
Develop and improve Quality Management Systems to facilitate business and Quality objectives.
Ensure timely independent Quality assessment of systems, reports, internal/external facilities and documents that meet the company standard for content and format.
Support resolution process to ensure the organization is alerted to issues in time to resolve potential adverse effects on the customer, company or business.
Ensures the selection, orientation, development, and retention of qualified staff to carry out the responsibilities of the department.
Manage project and company risks.
Communicate business related issues or opportunities to next management level.
Proficient in the use of a personal computer with intermediate level of keyboarding skills and proficiency in the use of Outlook, Word, Excel, PowerPoint, and Access.
Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, coaching, and team building.
Strong listening and assessment skills
Strong questioning and problem-solving skills
Strong engineering knowledge, especially in software driven electro-mechanical medical devices.
Knowledge and understanding of FDA regulations, ISO standards, and other industry standards for Medical Devices.
Good working knowledge of Statistical techniques: basic statistics, Statistical Process Control, Design of Experiments.
Understanding and practical experience in Design Control requirements.
Understanding and practical experience in Risk Assessment as applied to Medical Devices (e.g., FMEA, FTA, Hazard Analysis, etc.)
Knowledge and understanding of investigation techniques, 5 Why's, Ishikawa, etc.
Knowledge and understanding of Quality Assurance and Quality Engineering principles.
Knowledge and understanding of team functions, leadership techniques and project management methodologies.
Strong Project Management experience
Extensive knowledge of medical device regulations, industry or international standards and ability to interpret and implement.
Ability to understand Corporate, Division and Plant Quality Systems and be able to implement systemic changes to enhance product Quality and improve business efficiency at the Division & Plant levels.
Ability to interface with regulatory bodies to defend BDUCC compliance.
Highly variable operations performed daily from complex regulatory and engineering decisions to routing administrative functions. Interpretation of regulations (QSR, ISO requirements, EN60601) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, 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. Furthermore, this person's decisions could have a significant impact on health care practitioners and the welfare of their patients.
A great deal of self-directed work must be initiated through a detailed knowledge and understanding of the division 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.
B.S. in Engineering (mechanical, software or electrical) or equivalent experience. Master's Degree preferred.
Five (5) years of experience in managing Quality Assurance and Quality Engineering programs in the medical device and/or pharmaceutical industry.
ASQ CQE, CQA, and or CRE Certifications preferred.
Experience with Medical Device Capital Equipment, including Service and Repair for software-driven electromechanical systems is preferred.
Experience with Design Reliability and Field Reliability is preferred.
Primary Work LocationUSA CO - Louisville
BD (Becton, Dickinson And Company)