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Job Description SummaryThe Senior Manager, Division Quality Management establishes, directs and continuously improves Division functions including Quality Management Systems, Document Control, CAPA Management, Compliance and Internal Audit. This position will have direct or indirect oversight of these functions across the UCC business unit’s Quality system network, and be directly responsibility for the Covington / Madison site QMS and divisional compliance with the FDA / ISO 13485 Quality System Regulation, other FDA Regulations, and other international regulations and BD policies and procedures that apply to devices designed and manufactured by UCC. Additionally, the Sr. Manager, Division Quality Management functions as a subject-matter expert for MasterControl or similar EDMS system, Training, Internal Audits, Notified Body assessments, FDA audits, and CAPA, and quality systems compliance for UCC across the BD network.Job DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.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 carry out the responsibilities of the department.
Responsible maintain the UCC change controls processes, thru 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 ensure trained staffing for internal audits is maintained for the UCC network.
Ensures compliance to Department, Division and corporate procedures.
Tracks and trends Quality Indicators as defined by local, division, or corporate policies. Completes necessary business unit metric reporting to corporate, where applicable.
Interfaces with UCC manufacturing facilities or other Division functions.
Interprets corporate policies and regulations as to how they relate to prepare and implement Divisional procedures for conformance in the areas of responsibility.
Provides leadership for the overall CAPA process, ensures the functioning of the CAPA Board, overall system performance meets procedural expectations. Team members may have direct accountability for QMS related CAPAs.
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 at prescribed intervals.
Develops, reviews and maintains Quality Policies for the Division.
Reviews Corporate Quality Audit Reports and prepares appropriate corrective action responses.
Interface with Operations, Quality, and other segment level functions to define overall strategy in the areas of responsibility.
Develop team goals and ensures that quality / operational plans are aligned with business objectives and meet regulations.
Participate and have membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
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, 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 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. 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.
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.
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) years experience in a decision-making position as a Quality professional or equivalent quality related experience with at least five (5) years’ 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.
Minimum 7 years’ managerial or supervisory experience with proven track record of successful development of personnel.
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.
Six Sigma Black Belt or equivalent Root Cause Analysis methodology training desired
LANGUAGE SKILLS:English required.
REASONING ABILITY:Complexity: Highly variable operations performed daily, from complex regulatory and engineering decisions to routine administrative functions. Interpretation of regulations (QSR, ISO requirements) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary. This position involves reviewing and making decisions involving Personnel, Statistics, Engineering, Document Control, Policy, Procedure, Specifications, and Regulatory Compliance issues.
Judgement: The position involves making decision involving all areas mentioned above. In some instances, there are written policies or procedures or standards that have to be interpreted. In some instances, only judgment based on past experience can be used. Decisions made by this person could have significant regulatory implications.
WORK ENVIRONMENT:This position is hybrid role, with expected 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.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Office environment
Manufacturing environments
May include visits to clinical sites or hospitals which require COVID-19 vaccination
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.To learn more about BD visit https://jobs.bd.com/At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under “Our Commitment to You”. The anticipated compensation range for this position is $137,700.00 - $140,000.00 and the compensation offered will depend on the candidate’s qualifications.BD follows the Pay Transparency and non-discrimination provisions described by the Colorado Department of Labor and Employment (CDLE).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, or any other protected status.PDNPrimary Work LocationUSA GA - Covington BMDAdditional LocationsUSA CO - LouisvilleWork ShiftBecton, 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, or any other protected status.