Sr. Quality Engineer

Requisition ID: 67297

Date: Sep 19, 2024

Location:

Cidra, Puerto Rico, US

Department: Quality

Description:

Who We Are:

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.

POSITION 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, validations and other projects to the QA Manager and/or other interested parties. Support customer complaint data acquisition, root cause analysis and draft complaint responses Performs all duties associated with compliance-related items for ISO standards and cGMps.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Support site Engineers/Quality Specialists in meeting customer expectations in complaint investigation responses. Aid in assuring expected turn-around time metric is attained.

• Support site 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

• Support ISO and corporate quality system audits as needed.

• Fills in for Quality Manager as requested or required.

• Performs other duties as assigned based on business needs.

REQUIRED QUALIFICATIONS:

• Education: Bachelor's Degree in Science (prefer biology, chemistry, engineering or industrial engineering focus)

• Experience: 5-8 years of experience

• Experience with Customer interface and meeting customer expectations

• Experience with Project Management Tools, Quality Risk Management, SPC tools and techniques, and Six Sigma problem solving tools.

PREFERRED QUALIFICATIONS:

• Experience in Microsoft Windows, Office 365 and Sharepoint a plus.

PHYSICAL & TRAVEL REQUIREMENTS:

• Must be able to travel 10-20% of time.

The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all of the work requirements that may be inherent in the job. West Pharmaceutical Services is an Equal Opportunity Employer

#LI-KR1

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.