West Pharma Sr Quality Engineer 

United States, Puerto Rico 

393065777

Supports all quality system and functions. Assists in establishing systems to support the facility to drive continuous improvements and minimize the costs of non-conformance. Plans, schedules, executes and communicates all items regarding quality issues, validations and other projects to the QA Manager and/or other interested parties. Support customer complaint data acquisition, root cause analysis and draft complaint responses Performs all duties associated with compliance-related items for ISO standards and cGMps.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Support site Engineers/Quality Specialists in meeting customer expectations in complaint investigation responses. Aid in assuring expected turn-around time metric is attained.
• Support site staff in usage of tools and processes for customer complaint investigations/continuous improvement.
• Analyze data, process capabilities, customer concerns and expectations and any other leading or lagging indicators which may be used to improve product and process knowledge.
• Interact with customers to understand and integrate those requirements into West manufacturing and quality system requirements.
• Identify manufacturing and development constraints. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to
preclude recurrence.
• Assists facility with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques
• Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation
of any new or required inspection methods and in-process SPC programs
• Support ISO and corporate quality system audits as needed.
• Fills in for Quality Manager as requested or required.
• Performs other duties as assigned based on business needs.

REQUIRED QUALIFICATIONS:

• Education: Bachelor's Degree in Science (prefer biology, chemistry, engineering or industrial engineering focus)
• Experience: 5-8 years of experience
• Experience with Customer interface and meeting customer expectations
• Experience with Project Management Tools, Quality Risk Management, SPC tools and techniques, and Six Sigma problem solving tools.

PREFERRED QUALIFICATIONS:

• Experience in Microsoft Windows, Office 365 and Sharepoint a plus.

PHYSICAL & TRAVEL REQUIREMENTS:

• Must be able to travel 10-20% of time.

The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all of the work requirements that may be inherent in the job.