Quality Assurance Operations Manager

Category: Manufacturing/Medical Device
Job ID: 2018-11070
Career Level: experienced
Division: Moncks Corner/BMD
Relocation: Yes
Location: Moncks Corner,South Carolina,United States
Summary of Position with General Responsibilities:
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
Essential job Functions:
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.
Basic Qualifications:
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.
Additional Desirable Qualifications Skills and Knowledge:
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.

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