West Pharma Sr Quality Engineer 

United States, Nebraska 

822690524

Job Summary:

Lead product and process improvements by collecting, compiling and analyzing data. Drive continuous improvement projects relating to both sustaining engineering and product development activities. Participate in steering committees which originate from both corporate and manufacturing facilities.

Essential Duties and Responsibilities:

1. Analyze appropriate data and identify projects to reduce the Cost of Poor Quality, improve quality of products and Yield Opportunity to 100%.
2. Maintain information and statistics on site’s quality performance on a frequent basis including the site’s Cost of Quality data.
3. Author/support new standards and procedures for the Site and/or the Enterprise.
4. Meet company and departmental goals in the continuous improvement of quality of products, services and processes.
5. Provide quality reports and review trending on assigned areas of responsibility.
6. Perform DOE’s (Design of Experiments) to help improve and optimize new and/or existing plant processes
7. Work independently and with project teams to develop design control deliverables including quality plans, manufacturing & inspection documentation, test methods, and any necessary records for compiling design history file where applicable.
8. Lead quality assurance improvement activities by evaluating products, processes, and data to develop control or improvement strategies intended to improve the customer’s experience.
9. Lead the development and maintenance of product risk and hazard analysis.
10. Support critical quality issues investigation using appropriate quality tools (5Whys, A3, etc)
11. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.
12. Support both corporate and facility driven initiatives intended to meet defined objectives.
13. Support technology transfer products between West sites
14. Perform internal ISO and quality systems audits in accordance with ISO standards including recommending ways to resolve any issues identified by the audits
15. All other duties as required.
16. Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
17. Exhibits regular, reliable, punctual and predictable attendance .

Basic Qualifications:

Education: Bachelor's in...

• Science or Engineering, or commensurate experience

5+ years of experience in…

• Quality Assurance / Quality Control / Quality System

Preferred Knowledge, Skills and Abilities:

• Experience with Customer interface and meeting customer expectations.
• Demonstrate team building and problem-solving skills
• Ability to effectively prioritize and escalate issues
• Working familiarity with Project Management Tools and Quality Risk Management.
• Working knowledge of ISO requirements (15378) and Pharmaceutical Industry requirements (cGMP, etc)

• Six Sigma Black Belt with DOE experience preferred

Travel Requirements:

• Minimal Travel for customer interface

Physical & Mental Requirements:

• Work in a manufacturing environment, subject to heat and cold as well as loud noise.
• Work in an office environment. At times must sit for extended periods of time.
• Ability to effectively communicate and comprehend complex ideas and concepts.