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Bausch Health Quality Engineer II in Rochester, New York

Quality Engineer II (5008)

Career Opportunities: Quality Engineer II (5008)

Requisition ID 5008 - Posted - Contact Lens Development - R&D - US - Rochester, NY (GEHC)

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.

Position responsibilities:

Provide technical support of Departmental Technical Documentation activities and the development, implementation, and effectiveness of Development Process Engineering’s (DPE’s) procedures and systems for compliance to the quality directives. This includes but is not limited to gap assessments of directives and DPE’s processes and procedures, training, procedure effectiveness, metrics for tracking performance, qualification & validation support of equipment, facilities and software, conducting risk assessments, technical writing and electronic filing and storage of information, support internal audits and corrective actions.

Responsibilities:

Support Process Engineering Lab Quality Directives gap analysis and closure plan execution. Helping perform risk assessments, investigations, documentation and procedure updates, qualification writing and execution. Drive effort to manage DPE’s SOP’s to ensure GMP, FDA and ISO compliance. Support Compliance and Documentation Systems for DPE:

  • Global Document Management System for protocols/reports and procedures.

  • CATSWeb for non-conformances and CAPA’s.

  • Compliance Wire Learning Management System for training.

  • Kintana for change control.

Conduct risk assessments as they pertain to Quality System compliance.

Support systems for PM’s, Calibration, Environmental Monitoring, and storage of clinical trial materials and products.

Manage and maintain the Master Validation Plan for the qualification and requalification of equipment, facilities, and software.

Write, manage, and maintain qualification/requalification activities for equipment, facilities, and software in the R&D Process Engineering Labs.

Review clinical protocols, batch records, and reports to ensure compliance to the product specifications and procedures.

Update quality metrics for tracking performance of the R&D Process Engineering Labs

Qualifications and experience:

Bachelor's Degree in Science/Engineering with Quality Engineering experience and/or certification as a Quality Engineer.

Specialized Training: ISO-9000, GMP, medical device manufacturing experience, technical writing, equipment and software qualification and documentation, LEAN/Six Sigma, clean room compliance.

Minimu of 3 years’ experience in a technical organization. Regulated Medical Device or Pharma industry a plus. Minimum of 3 years’ experience with medical device and/or clean room environment compliance regulations required.

Special Skills: Computer competent with Microsoft Office Suite; ability to learn specific software systems utilized in B&L’s growing Quality Systems (Documentum, Kintana, CATSWeb). Actively participating in Process and Design FMEA activities as required. Use and knowledge of Lean and DFSS tools and software desired. Communication, Organization, Report Writing a must. Must be able to develop working relationships with various internal core competencies and work as a team member

This position may be available in the following location(s): US - Rochester, NY (GEHC)

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.

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Bausch Health is an EEO/AA employer M/F/D/V.

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