BD (Becton, Dickinson and Company) Quality Assurance Operations Manager in Moncks Corner, South Carolina
The purpose of the Quality Assurance Operations Manager is to maintain and improve the Quality systems in place in the Moncks corner site to assure compliance, continuous improvement and establishing / tracking adequate metrics. This position is responsible for maintaining a department of qualified and motivated Quality Engineers, Technicians and Specialists. This includes providing all Quality Engineers, Technicians and Specialists with the proper tools and guidance to be successful in performing their respective job responsibilities, as well as providing them with a work environment conducive to personal and professional success emphasizing continuous improvement. Additionally, the QA Operations Manager functions as a subject-matter resource for Quality Systems, Compliance, Validation and Calibration systems
+ + Responsible for assuring that systems in place are adequate for manufacturing compliant products and capturing and addressing non-conformances in a timely manner.
Responsible for maintaining and implementing improvements associated with procedures, systems, controls, reviews and personnel involved with CAPA programs, Management Review, Incoming Quality Control and In process and Finished Goods Quality inspection and/or testing.
Analyzes process and product non-conformances and implements comprehensive corrective and preventive action plans.
Ensures compliance to Plant, Department, Division and Corporate procedures.
Oversees Complaint reviews and investigations.
Tracks and trends Quality Indicators.
Creates, or reviews and approves Quality System Documents
Creates or reviews, and approves Protocols, Process and Product Validations, Stability Protocols
Actively participates in onboarding and development of subordinates.
Reviews and approves documents required for Design History File.
Reviews and approves Risk Assessment documents such as PFMEA and DFMEA.
Interfaces with manufacturing facilities or other Division Facilities.
Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems.
Extensive knowledge of medical device regulation, industry or international standard, including management responsibility.Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information.
Has experience in writing and review / approval of protocols/validations and has fundamental knowledge of validation principles.
Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE.
Ability to serve in leadership roles on projects or assignments.
Comprehensive understanding of auditing principles. Broad knowledge of manufacturing processes.
Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
Understands Fundamentals of Engineering Principles.
Ability to effectively manage time.
Ability to handle multiple task assignments.
Ability to translate quality requirements into product specifications.
Ability to interpret Regulations, Corporate, Division, Plant and Department Procedures.
B.S. in Engineering, Engineering Technology, Science as a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.), highly desirable
Minimum of 5 years of experience with FDA regulated industry
Minimum of 3 years personnel management experience
While performing the duties of this job, the employee is frequently required to stand; walk; use hands or arms (to finger, handle or feel objects, tools, or controls). The employee is frequently required to sit; occasionally to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.
The noise level in the work environment is normally quiet to moderate.
Industry Standard/Category: Manufacturing/Medical Device
Career Level: experienced
Division Name: Moncks Corner/BMD
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
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.