Bausch Health Senior Design Quality Engineer - Surgical in St Louis, Missouri
Bausch Health is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization's potential and what we hope it will become.
Provide support for Surgical development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility. Additionally the role will support marketed product changes and updates (MOB). The role includes working with multidisciplinary teams to insure medical device development activities are planned and executed in compliance with Design Control Requirements and Bausch + Lomb/Bausch Health procedures. Provide Quality Assurance support to sites as needed.
Work with Project Management to lead design teams through lean development methodologies to develop highly capable products. Drive test strategies meeting right first time expectations.
Currently there are no direct or indirect reports associated with this position.
Represent Design Quality on multi-disciplinary new product development and MOB teams. Duties will include:
Ensure project plans adequately address design, validation and Quality departmental requirements and standards. Work with functional departments to ensure tasks are executed compliantly. Management and documentation of Design Control activities through post launch review (approximately 1 year post launch).
Documentation of Risk Management requirements per ISO 14971.
Review/approve GMP documents (e.g. production records, analytical method validation, engineering/validation protocols/reports, specification updates (DCO's, QCR's)
Facilitate GMP production readiness and launch activities, including technology transfer and validation.
Support Quality System development and improvement with respect to GMP systems and development team compliance to ISO and FDA regulations.
Support post launch design changes and product updates as required.
Bachelor's Degree (BS) in engineering or scientific discipline (Chemistry, Biology, Microbiology).
3 years of experience in Medical Device and/or Pharmaceutical Industry in Quality, R&D, Engineering or Laboratory environment.
3 years developing and implementing product requirements in compliance with US federal and international regulatory standards relating to medical devices.
3 years using Six Sigma, DFSS or Lean Development techniquesin regulated environment
1 year utilizing corrective and preventive action (CAPA) system that is in compliance with US federal and international regulatory standards relating to medical devices.
1 year Complaint management, complaint review and corrective action.
1 year Utilization of root cause analysis tools, including fault tree analysis, 5 Whys, Is/Is Not,
1 year risk analysis experience.
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Bausch Health Companies Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. 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 ID 10658
Pos. Type Full Time