Ensures that a Quality Management System for Specialty Vision Products business is implemented, maintained, and effective for product manufacturing, control, storage, and primary distribution processes in accordance with Bausch Health Quality Manual, Quality System Directives, all applicable Quality Systems standards and regulations (i.e. FDA QSR, ISO 13485:2012, MDD, and Canadian SOR etc.)
Responsibilities include, but are not limited to: validations, NC/CAPA system, GMP documentation, complaint investigations, design control, risk management and change control, supplier quality management, implementation of regional quality systems and requirements, GMP and ISO quality system training, preparation of management and product quality reviews.
Includes establishing business/site specific Quality Plans, objectives, appropriate quality metrics and management updates.
Includes the preparation and maintenance of Quality budgets and the training/growth/development of Quality personnel.
Scope of position:
Full responsibility for Quality function for assigned site(s) including overall responsibility for the Quality Management System and State of Compliance.
Ensurins compliance with Bausch Health Quality Manual and Quality System requirements.
Implementation and management of an effective, efficient and compliant (E²C) Quality Management System for the Specialty Vision Products operations.
Establishment and ongoing development of an effective Quality team to support the growth of the Specialty Vision Products business.
Collaborate with Operations to identify and implement continual improvement initiatives to drive the long-term success and profitability of the Specialty Vision Products business.
Quality assurance, Gmp, Qa, Pharmaceutical, Batch record review, Batch record
Bachelor's Degree BS in engineering or scientific discipline (Chemistry, Biology, Microbiology or related technical field).
Minimum 10 years of experience in Quality assurance, Quality systems, or Quality management in the medical device industry. Proven track record of accomplishment in leading an operation/business in the development, implementation and management of a successful Quality Management Strategy and program.
Must possess a deep understanding of applicable Quality System requirements/regulations and how they are applied in an efficient, compliant manner.
Desired: Five+ years Quality Assurance experience in a high-volume manufacturing facility, including successful interactions with regulatory agencies. Six Sigma GB, BB, or MBB preferred.
Five+ years in management, with a proven track record of successful people management and development of personnel.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.