Title:  Sr Quality Engineer

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

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, 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:

• 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 in order 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.
• Manage the CAPA process including the review and approval to open new CAPAs as well as approving CAPA plans, timelines and verification of effectiveness plans to assure timely completion within the established goal.
• Lead investigation and root cause analysis to internal deviations, non-conformance reports, FIAP- Foreign Action Plan and OOS.
• Support validation of facilities and equipment and process. Approve engineering studies and other protocols as required.
• Oversee Calibration and pest control activities.
• Complete MSAs for critical measurement systems and provide recommendation for gauging improvements.
• Assist with the administration of the SPC data collections system and associated training of employees in SPC.
• Performs other duties, as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

Basic Qualifications: 

• Bachelor’s in Science or Engineering or equivalent experience
• 5-8 Years of experience 

Preferred Knowledge, Skills and Abilities:

• Experience with Customer interface and meeting customer expectations
• Experience with Project Management Tools, Quality Risk Management, and Six Sigma problem solving tools
• Experience with SAP and SharePoint a plus
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
  • List any safety requirements applicable to role within your country
• Able to comply with the company’s quality policy at all times.
  • List any quality requirements applicable to role within your country

Travel Requirements:

• Must be able to travel up to 20 % of the time

Physical & Mental Requirements:

• Must be able to read and write.
• Good communication skills to interact with others in a positive manner.
• Must be able to understand direction and adhere to established procedures.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.