Quality Operations Manager

Job ID: 2017-10857
Career Level: experienced
Division: Moncks Corner/BMD
Relocation: Yes
Location: Moncks Corner,South Carolina,United States
The purpose of this position 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, Supplier Quality Engineer, Validation Engineers, QA Supervisor, Technicians and Specialists. This includes providing all Quality, Supplier and Validation Engineers, Supervisor, 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 and Validation systems.
Essential job Functions:
Manage and effectively lead quality engineers, lab supervisors and other quality team members as deemed necessary.
Hire, train, develop, and manage exempt and non-exempt employees.
Ensure effective and meaningful development plans are in place for direct reports.
Administer the testing and controlling of raw material, in-process, and finished product quality, assuring compliance with company standards and applicable government regulations.
Coordinate / perform customer complaint investigations according to plant and corporate QA guidelines, conduct trending on customer complaints, and effectively communicate to upper management.
Coordinate and conduct routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP's and corporate standards. i.e. QMS , QSIT, Combination Products, Regulatory requirements; Notified Bodies, etc
Participate / lead quality improvement activities pertaining to customer complaints or adverse quality trends.
Conduct internal audits and coordinate corrective actions and closure for internal and external audits as necessary.
Perform continuous quality control evaluation and trend analysis on product quality issues, resolve quality issues and initiate corrective actions with other departments as required.
Assist with the preparation and maintenance of department budgets. Maintains comprehensive knowledge of applicable regulatory authority quality and regulatory requirements and their interpretation.
Facilitate QA/QE support for new product launches to ensure robust development, validation (IQ, OQ, PQ), rollout, and implementation.
Coordinate with Operations and Engineering in developing and implementing projects for improvement of processes / products.
Provide feedback to Operations on opportunities related to quality and/or compliance.
Draft appropriate documents to support the Quality systems. Support the document control and project management systems.
Support the vendor qualification/assessment requirements of the facility.
Make decisions on product/process quality based on evaluations.
Basic Qualifications:
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
B.S. in Engineering, Engineering Technology, Science as a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.), highly desirable
Minimum 5 years of experience with FDA regulated industry Management roles highly desirable.
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 proven 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.

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