Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
Be 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.
The Plant Quality Manager is responsible for the general management of the Moncks Corner Quality Management System and the overall Quality function to assure compliance to Local, State, Federal, and International regulations and requirements. The Plant Quality Manager is also responsible for the planning, development, and implementation of quality systems that support the Moncks Corner business objectives and resources.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Represent the Corporation, Division and Quality Department in a professional manner.
Serve as Management Representative with authority and responsibility for assuring an effective quality system and periodically reporting on performance to management.
Manage and ensure proper implementation of all Quality duties and responsibilities. Hire, train, develop, review, and manage exempt and/or non-exempt employees as assigned.
Provide Quality Assurance technical support to assist in resolving quality issues, including but not limited to complaint review and investigation.
Create, review and approve Quality System Documents
Create, review and approve Protocols, Process and Product Validations, Stability Protocols etc. to support the products manufactured in the Moncks Corner facility.
Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA).
Perform Internal and Supplier Quality Audits.
Leads all facility audits (FDA, ISO, Corporate, Division, etc.).
Provide technical support for complaint and adverse event review and investigation.
Collaborate with other manufacturing facilities or other Division Facilities as required.
Optimize quality systems to effectively identify, measure, and reduce the cost of quality activities.
Design reporting systems which provide visibility of key quality metrics and provide leadership in establishing, reporting, implementation, trend analysis and corrective action to improve quality metric trends (i.e., rejections, scrap, complaints, etc.)
Strong Verbal and written communication skills and presentation skills.
Technical writing skills.
Knowledge and understanding of Document Control practices.
Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Corporate, Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to work with regulatory bodies to present technical information.
Experience in writing protocols/validations and fundamental knowledge of validation principles.
Understanding of applied statistics, statistical sampling plans, and statistical process control.
Ability to serve in leadership roles 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. Understanding of team functions, leadership techniques and project management methodologies.
Broad knowledge of manufacturing processes.
Ability to effectively manage time.
Ability to balance multiple task assignments.
EDUCATION and/or EXPERIENCE:
Four (4) year Engineering or Science degree.
Eight (8) + years experience in a decision-making quality engineering position or equivalent quality related experience with at least 2 years in FDA Regulated Industry.
American Society of Quality (ASQ) Certified Quality Engineer or Certified Quality Manager desired
Six Sigma Black Belt training desired
College level mathematical skills.
Basic applied Statistics, statistical sampling plans, statistical process control, DOE, Taguchi Methodology.
Able to take theoretical mathematics and apply to business problems.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
May include visits to clinical sites or hospitals.
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/
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.
Primary Work LocationUSA SC - Moncks Corner
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Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
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