Responsible to assure Quality and Compliance, and provide overall Quality guidance during product design and development, design verification and validation, and design transfer to manufacturing.
-Represent Design Quality on multi-disciplinary new product development and MOB teams.
-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.
-Responsible to defend in any Quality audits and Regulatory inspections the Design Quality aspect of the products under his/her responsibility.
-Owns and leads CAPAs initiated for findings in Design Quality procedures and practices.
-Identify, develop and implement specific metrics to monitor Design for Quality across product lines with active R&D projects.
-Provides coaching and training on critical Quality procedures and practices to entry level Design Quality Engineers and/or contractors as part of their onboarding process.
-Perform assessments of Quality processes and procedures relative to product design and development, in order to identify potential inefficiencies, and where needed, propose and implement changes to improve those processes.
-Proactively participates as owner of site Quality deliverables in corporate projects and initiatives towards continuous improvement of product Quality and/or the Quality management system.
Scope of Position:
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
Represent the Design Quality team at Corporate or Global Quality projects.
- Bachelor’s Degree (BS) in engineering or scientific discipline (Chemistry, Biology, Microbiology).
- Thorough understanding of Design Controls requirements for medical devices, as well as best practices that foster high quality design.
- Deep knowledge of Design History Files.
- Excellent analytical, problem solving, organizational, and communication skills
5 years of experience in Medical Device and/or Pharmaceutical Industry in Quality, R&D, Engineering or Laboratory environment.
5 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 techniques in 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.
3 years risk analysis experience.