Requisition ID: 73920
Date: Jul 10, 2026
Location:
Waterford, IRL, IE Exton, PA, US, 19341 Dublin, L, IE
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Department: Quality
Description:
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week
No relocation is provided for this opportunity
Who We Are:
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
What We Offer
Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration.
Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
Job Summary
In this role, you will provide quality direction, governance, and Quality Management System best practices across the programs you support. This role oversees multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment. You may supervise the daily activities of the customer program Quality Engineers responsible for planning, scheduling, executing and communicating all items regarding quality issues, complaints, validations and other projects in support of Customer Program Operations and product release. You may ensure suppliers deliver products which comply with requirements and specifications. You may lead efforts to enhance the supply chain by addressing supplier and customer issues, improving quality processes internally and with suppliers, and executing quality strategies. You may play a key role in developing and maintaining quality engineering methodologies, collaborating with cross-functional teams, guiding technical evaluations, and implementing improvements in the Quality Management System
Essential Duties and Responsibilities
Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met.
Provide Quality Engineering direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements, including ensuring all relevant safety procedures are employed.
Support the certification efforts to transition the Integrated Systems Laboratry to be acreditted for ISO 17025, by completing a gap assessment, identification of actions, and managing the completion of the actions.
Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.)
Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures and ISO standards.
Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions.
Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
May work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any other necessary quality records. Provide quality reports and review trending on assigned areas of responsibility.
May 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.
May 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 Statistical Process Control programs.
May perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols, and identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed.
May have people management responsibilities.
Other duties as assigned.
Education
Bachelor's Degree in Engineering or Science or equivalent experience required
Work Experience
Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities required and
Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required and
In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971 required and
Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required and
Preferred Knowledge, Skills and Abilities
Experience with MasterControl, SAP, Share Point, Teamcenter
Experience with ISO 11040, ISO 11607
Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
Strong working knowledge of quality systems of the respective ISO norms
Strong working knowledge of statistical theory and application to understand output control and capability, hypothesis tests for evaluating comparability, and coordinating design of experiment testing.
Working knowledge of supplier quality management from product development to mass production.
Strong project management skills
Proficient in computer system applications (SAP, master controls, etc) communication skills
Excellent critical reading and writing skills
Problem solving including root cause failure analysis methods
Be aware of all relevant SOPs as per Company policy as they relate to this role
Able to comply with the company’s safety and quality policies at all times
License and Certifications
Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
Quality\Certified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred
SO 17025 Auditor or Lead Auditor Training / Certification Upon Hire preferred
Travel Requirements
10%: Up to 26 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
Ability to work independently, multi-task and thrive in fast-paced environment.
Strong problem-solving skills including root cause failure analysis methods.
Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
Must maintain the ability to work well with others in a variety of situations.
Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
Must be able to multi-task, work under time constraints, problem solve, and prioritize.
Ability to make independent and sound judgments.
Observe and interpret situations, analyze and solve problems. #LI-NJ1 #LI-hybrid
Pay Transparency:
The annual base salary range for this position is €63200.00 - €80,500.00. Total target compensation is determined using objective and gender-neutral criteria, including relevant experience, qualifications, skills, market benchmarks, geographic location, and the scope and responsibilities of the role.
This position may be eligible for variable compensation and other incentive programs in accordance with the terms of the applicable plans within the country of employment. In addition, team members are eligible to participate in the company’s benefits and total rewards programs applicable to their location and employment status.
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
[email protected]. 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.
