Title:  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:

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 finance data and complete SSGB projects to reduce the Cost of Poor Quality and Yield Opportunity to 100%.
2. Author new standards and procedures for the Site and/or the Enterprise. 
3. Meet company and departmental goals in the continuous improvement of products, services and processes.
4. Provide quality reports and review trending on assigned areas of responsibility.
5. 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. 
6. Lead quality assurance improvement activities by evaluating products, processes, and data to develop control or improvement strategies intended to improve the customer’s experience.
7. Lead the development and maintenance of product risk and hazard analysis.
8. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.
9. Support both corporate and facility driven initiatives intended to meet defined objectives.
10. All other duties as required.
11. Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
12. Exhibits regular, reliable, punctual and predictable attendance.

Basic Qualifications: 

• Education: Bachelor’s in Engineering, Biology, Business
• Experience: 5 years of experience in manufacturing environment.   

• Ability to work independently and in a team environment. 
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement. 

Preferred Knowledge, Skills and Abilities:

• Six Sigma Black Belt with DOE experience preferred
• 5 years experience in pharmaceutical environment in quality or engineering. 
• Knowledge of ISO 9001, ISO 13485 or 15378, 21 CFR 820, 21 CFR 210 & 211, cGMP

• Must possess or be willing to develop: 

• Problem solving skills:  Lean Six Sigma Green Belt, preferably Lean Six Sigma Black Belt with DOE experience. 
• Effective presentation/communication skills, both oral and written, project/resource management skills. 
• Must be able to travel by air and car and work occasional weekends. 
• Comply with safety regulations and promote safe working environment. 
• Ability to manage multiple projects in a fast-paced environment. 

• 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
• Able to comply with the company’s quality policy at all times.

Travel Requirements:

• Minimal

Physical & Mental Requirements:

• Perform job duties as required with limited physical demands and some travel may be required.

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.