West Pharma Quality Project Engineer 

United States, Michigan 

69102355

Job Summary:

In this role, you will support 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, complaints, validations and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMps.

Essential Duties and Responsibilities:

• Support site Quality Engineers/Quality Specialists in meeting customer expectations in complaint investigation responses. Aid in assuring expected turn-around time metric is attained.
• Assist in developing site Quality Engineer 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.
• Participates in ISO and corporate quality system audits.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Exhibits regular, reliable, punctual and predictable attendance .
• Other duties as assigned.

Basic Qualifications:

• Bachelor’s degree in Manufactring or Mechancial engineering or similar degree.

Preferred Knowledge, Skills and Abilities:

• 3+ years relative experience in an engineering role
• Quality engineering experience in a pharmaceutical or medical device manufacture.
• Able to interface with customers and meeting customer expectations.

• Experience with Project Management tools and able to provide support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.