BD (Becton, Dickinson and Company) Quality Assurance Director- HomeCare in Covington, Georgia
Bard has joined BD, together advancing the world of health. BD Urology & Critical Care, formerly Bard Medical, is looking to fill the Director-Quality Assurance (HomeCare) position at our Covington, GA division headquarters.
The Home Care Director of Quality establishes, directs and ensures that all Home Care devices are in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations that apply for design, manufacture, distribution and support. The Home Care Director of Quality has the authority, responsibility and accountability for all activities and associated documentation related to Home Care products.
Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
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.
Collaborates with Quality functions at non-UCC plants to ensure UCC products are transferred effectively, on-going production meets specifications and key projects and process improvements are jointly supported.
Maintains and enhances UCC Home Care compliance to ISO requirements and other international regulations.
Analyzes internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards, Corporate quality standards, and Divisional and Facility quality standards.
Develops, reviews and maintains Quality Policies for the UCC Home Care portfolio.
Responsible for the investigation of product and process quality and manufacturing issues.
Performs periodic complaint trend analysis and makes recommendations and reviews associated action plans for complaint reduction.
Keeps the Management Board iormed about quality-related problems and issues.
Reviews Corporate and ISO Quality Audit Reports and prepares appropriate corrective action responses.
Travels to Division Operations Facilities and to supplier locations to carry out the duties described above.
Analyzes audit non-conformances and implement comprehensive and 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.
Support Home Care field actions, including recalls and field notifications and support FDA reporting activities until recall is complete.
Host FDA, Notified Bodies, and internal audits. Responsible to assure the corrective actions to any audits are implemented in a timely fashion.
Define, lead and implement quality engineering in the design and development of products, and in transfer and steady state phases of manufacturing operations.
Ensure timely independent quality assessment of systems, reports, internal/external facilities and documents that meet the company standard for quality and format.
Resolution process to ensure the organization is alerted to issues in time to resolve potential adverse effects on the customer, company or business.
Support licenses and acquisitions by investigating levels of compliance, quality and reliability of potential technologies and/or companies (due diligence).
Oversee the analyses, evaluation, and presentation of information concerning compliance audits associated with GLP, GCP and/or GMP requirements.
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 electrical, 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 / 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 BMD compliance.
Experience with manufacturing large volumes of sterile single use devices.
Well versed in English language skills, both verbal and written.
Able to communicate to multiple levels within the organization.
Able to communicate within cross functional teams.
- Well versed in statistics, analytical reasoning skills based on data.
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, electrical, software or other engineering) or equivalent experience. Master’s Degree preferred.
Eight years of experience in managing QE/QA programs in the medical device and/or pharmaceutical industry.
ASQ CQE and CRE Certifications preferred.
While performing the duties of this job, the employee is regularly required to sit, stand, and walk. At times, the employee is required to climb or balance and stoop, kneel, crouch or crawl. May occasionally lift objects of 10 to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Office and manufacturing environments may include visits to manufacturing & clinical sites or hospitals. #LI-CW1
Industry Standard/Category: QA Director/Quality Assurance
Relocation Available?: Yes
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 8195 Industrial Blvd.
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.