Senior Quality Engineer (4694)
Career Opportunities: Senior Quality Engineer (4694)
Requisition ID 4694 - Posted - US - Wilmington - Quality - US - Wilmington, MA - City (392)
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
Serve as a Quality ambassador to improve awareness, visibility and communication on quality initiatives and to support assigned departmental, functional, site, divisional and corporate quality goals and priorities within the Specialty Products Vision Care of Bausch Health.
Develop and maintain risk management files and pFMEAs for new processes and process changes.
Support validations for new and existing products, processes and equipment.
Manage NC/CAPA teams through identification and development of corrective action plans, verification and closure.
Coordinate and support supplier quality management activities, including qualification and evaluation, supplier investigations, etc…
Manage and support batch record review and disposition of product.
Support and prepare for site-level internal, external, supplier and customer audits.
Apply systematic problem-solving methodologies and provide quality support to identify and resolve quality issues to ensure production of safe and effective medical devices.
Identify and implement opportunities for continuous improvement.
Interact and coordinate activities with other departments, external vendors and customers.
Perform other Quality System related duties as required.
Bachelors degree required, preferably in Engineering, Science (Chemistry, Biology, Physics, etc) or Math (Statistics).
5-8 years of experience in roles with increasing levels of complexity and scope.
Experience in an FDA regulated manufacturing or industrial environment.
Strong working knowledge of FDA / ISO 13485 Quality System. requirements, GxP, and other relevant standards and regulations.
Technical skills and experience related to process validation, statistical methods, and risk management.
Experience performing quality audits. Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred.
Lean manufacturing / Six Sigma helpul
Strong cross-collaborator, effective coaching and mentoring skills
Ability to work independently, well organized and self-driven.
Excellent written and verbal communication skills.
This position may be available in the following location(s): US - Wilmington, MA
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
Bausch Health is an EEO/AA employer M/F/D/V.