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.

Summary:

To ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements. Developing and implementing continuous improvement programs covering production processes and quality management systems Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure. Lead investigations for quality issues, deviations.

Review and approve validations reports. Act as QA representative for site projects, participate in steering committees which originate from both corporate and manufacturing facilities.

Lead / participate in quality improvement projects.

Essential Duties and Responsibilities:

• Review and approve product / process deviations or rework documentation.
• Provide quality reports and review trending on assigned areas of responsibility.
• 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.
• Participate in the development and maintenance of product risk and hazard analysis in accordance with ISO 14971.
• Meet company and departmental goals in the continuous improvement of all products, services and processes.
• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.
• Maintain information and statistics on our site’s quality performance on a monthly basis including the site’s Cost of Quality data.
• Fill in for the Quality Manager as requested or required.
• Perform DOE’s (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols.
• Perform internal ISO and quality systems audits in accordance with ISO standards including recommending ways to resolve any issues identified by the audits
• 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: 

• Education: BS/BA degree preferably in a technical discipline including Business, Operations, Science
• Experience: 3-5 years of experience

• Excellent communications (including both written & oral methods), interpersonal, problem solving (including root cause failure analysis methods), planning/organizational, negotiating and computer skills required (especially MS Office applications & statistical analysis systems); general understanding of manufacturing and plant operations are also required.  

Preferred Knowledge, Skills and Abilities:

• Experience with ISO 9000 standards and GMP’s.
• cGMP's knowledge 
• Rubber manufacturing process knowledge required 
• ASQ certification highly desired.
• Black Belt certification a plus.
• Chemistry or Engineering degree preferred.
• Graduate degree (MS) a plus.

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.