Manual QA role focusing on product quality assurance for software development. Engaging in test case creation and collaborating with teams to ensure defect resolution for optimal quality.
About the role
- Sr. Quality Engineer at West Pharmaceutical Services overseeing projects and addressing quality issues. Collaborating across teams to ensure compliance and continual improvement in quality management.
Responsibilities
- Oversee projects, maintain processes and address quality issues by analyzing outcomes and collaborating with teams
- Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes
- Create processes to better evaluate, track and trend audit outputs and identify risks/issues
- Independently performs supplier audits and corporate facility audits
- Manage multiple project tasks and effectively coordinate handling of customer feedback and complaints
- Lead assessment and closure of customer complaints, ensuring adherence to established procedures and documentation
- Lead the evaluation and resolution of customer complaints
- Coordinate communication between internal teams and customers
- Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication
- Reviews, revises, and creates operating procedures to ensure compliance
- Establish monthly KPI’s and metrics to Quality Leadership
- Drive continuous quality improvement projects across the enterprise for increased compliance and efficient use of company resources
- Review and approve laboratory procedures, work instructions, protocols, reports, etc.
- Liaise and collaborate with departments to initiate, investigate, review and approve OOS investigations and reports
- Conduct root cause analysis and issue appropriate corrective action
- Plan, host and co-ordinate Customer, ISO, Corporate QA, and Regulatory audits/inspections
- Coordinate responses to customer audit observations, customer complaints and request for information/documentation
Requirements
- Bachelor's Degree In Engineering or Science required
- Master's Degree In Engineering or Science preferred
- Minimum 5 years Experience in regulated Quality Assurance / Document/Configuration Control required
- Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management preferred
- Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820 preferred
- Experience Leading Internal / External Audits, MasterControl, SAP and Share Point preferred
- Experience with customer interface and meeting customer expectations preferred
- Excellent written and verbal communication skills
- Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point.
- Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485
- Familiarity with root cause analysis tools
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members
- Maintain high attention to detail, accuracy, and overall quality of work
Benefits
- Supported by benefit programs
- Empower the physical, mental, emotional and financial health of team members and their families
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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