About bausch Advanced Technologies Inc.
Bausch Advanced Technologies Inc., a global leader in the pharmaceutical packaging machinery industry currently has an opening for a Quality Systems Specialist in our expanding Clinton, CT facility.
We are one of the top multinational manufacturers in pharmaceutical machinery with over 250 employees worldwide. The success and future development of all our companies are based on the know-how and personal competence of our qualified and highly motivated personnel. Our worldwide network of companies provides our customers with the advantage of faster and better service. If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Bausch Advanced Technologies Inc.
Quality System Specialist –
Job Functions:
Assist with development, implementation, and maintenance of a quality management system to assure FDA, and ISO compliance.
Execute NCE investigations ensuring complete and thorough review and timely closure.
Manage changes having GMP impact including process, equipment, and facility changes through Change Control process.
Provide support writing SOPs as needed.
Manage batch record product release.
Work with appropriate departments for efficient management of NCEs and CCs.
Train employees on all SOPs required for their particular job functions and maintain training records.
Qualifications:
BS Degree.3+ years of experience in a regulatory environment with proven track record of responsibility for product registration and compliance with medical devices.In-depth knowledge of regulations governing Medical Devices in the US, Canada and Europe (FDA, ISO13485, CE, CSA,FCC, MDD)Excellent verbal and written communication skills in English facilitating the preparation of technical presentations to customers, regulatory authorities and scientific bodies as well as internal communication at all levels of the company on matters of expertise.
Experience implementing ISO 13485 (ensuring full implementation of this standard is expected from existing and to-be-developed protocols)Experience with Good Laboratory Practices (GLPs)Experience in FDA 510k submissionKnowledge of international regulations governing product registration and complianceStrong team and interpersonal skillsExperience in a multi-disciplinary environment, with engineering, operations, and business functions closely cooperatingDemonstrated ability to set realistic goals and timetables to execute those goals with minimal supervision
This is a full – time, permanent position with a comprehensive benefits package – Medical, Dental, Life Insurance and 401(k) with a company match. Paid vacation, Personal and Sick days. Seven paid holidays per year.
Bausch Advanced Technologies is an Equal Opportunity Employer.
Job Type: Full-time
Salary: $40,000.00 to $60,000.00 /year
Please email resumes to: ctr@bausch-group.com