Sr Quality Engineer [Must Have Validation, Nonconformance and CAPA]

Job Summary

As directed by the Quality Engineering Leader, the Quality Engineer II or Sr Quality Engineer is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills. Successful performance requires close work with quality management, operations, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.

Job Responsibilities

• Experience with addressing any internal quality issues and help team to resolve it in timely manner with production, quality, and regulatory compliance need. Part of MRB team to help team to create or drive quality notification to release the material.
• Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities. Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out Of Tolerance activity support to the site and equipment owners.
• Experience performing supplier qualification including Audits and surveys with quality/purchasing/planning team to complete the supplier risk classification and supplier approval list. Support Supplier Corrective Action and Investigation activity to represent the Customer side.
• Experience on CAPA(Corrective Action and Preventive Action) for internal and external complaints or Non conformance or continuous improvement activities.

Education and Experience

• BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field
• Minimum of 3-5 years of experience in Medical Device, Biotech or Pharma Industry.

Knowledge and Skills

• Strong verbal and written communication skills; ability to write technical documents. Knowledge of quality system methodologies
• Statistical Analysis basic knowledge e.g Minitab or Excel
• Strong knowledge of Design Control, Process Validation and Supplier Management
• Strong understanding and knowledge on ISO 9001, ISO 14971 and/or ISO 13485 (Design Control, Supplier Management and Risk Management)
• Hands on experience using Six Sigma methodology
• SAP knowledge
• The ability to work in teams and independently with minimal supervision to obtain results as required.
• Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.

Physical Demands

• General physical requirements: Sedentary work
• Visual acuity requirements: Inspection / Administrative
• Motion and sensory requirements: Talking, hearing, and walking.

Work Environment

• Onsite or hybrid work model is considered
• Ability to be present in manufacturing area as needed to support quality investigation.