Job Information
West Pharmaceutical Services Sr Quality Engineer in Exton, Pennsylvania
Sr Quality Engineer
Requisition ID: 68969
Date: Mar 6, 2025
Location:
Exton, Pennsylvania, US
Department: Quality
Description:
Candidates who are applying must be residing within a 50-mile commutable distance from the job location. This is a hybrid position (3 days onsite) located at Exton, PA
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.
Job Summary
In this role, the Senior Quality Engineer provides quality direction, governance, and Quality Management System best practices to syringe and drug containment programs. This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment.
This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets. They will partner with R&D, Regulatory, Supplier Quality, Analytical Labs, Supply Chain, and Operations to ensure consistency across product platforms which promote development and manufacturing high volume efficiencies and ensure product platforms are compliant with regulatory and business requirements throughout the complete development lifecycle including commercialization, sustainment, and post market surveillance activities.
The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. This role is also responsible for Quality oversight of documentation submitted to regulatory authorities in support of commercial launch and life-cycle management.
Essential Duties and Responsibilities
Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
Product Development, Risk Management, and Manufacturing :
Partner with R&D to provide Quality Engineering direction to multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements, ensuring sustainable and scalable solutions..
Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.)
Oversee and provide direction to cross-functional teams on product development DHF/DMR documentation including but not limited to failure analyses, risk management activities, FMEAs (application, design and process), process flow analyses, design of experiments, process capability analyses, quality inspection procedures including sampling plans, and test method validation
Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures.
Partner with R&D to ensure successful design transfers of new or updated products and manufacturing transfers from Product Development into Manufacturing, in collaboration with Operations and third party providers.
Additional Responsibilities
Quality Management System :
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
Drive proactive, preventative behaviors and via a strong CAPA and to resolve product quality issues for commercialized products.
Miscellaneous:
Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
Drive continuous quality improvement projects
Other duties as assigned
Education
Bachelor Degree in Engineering or Science required
Relevant work history and/or experience may be considered in lieu of degree
Work Experience
Bachelor Degree in Engineering or Science required
Minimum 6 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities
Relevant work history and/or experience may be considered in lieu of degree
In-depth knowledge of cGMP regulations, ISO 11040, ISO 15378, ISO 13485, 21 CFR 820, ISO 14971, EU MDR
Preferred Knowledge, Skills and Abilities
ASQ certification (CQE or CQA)
Green or Black Belt certification
Experience with MasterControl, SAP, Share Point, Teamcenter
Experience with EU GMP Annex I, and PDA a plus
Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
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
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
License and Certifications
Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
Quality\Certified Quality Engineer - ASQ (CQE or CQA) Upon Hire preferred
ISO 13485 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
Observe and interpret situations, analyze and solve problems
Effectively communicate and interface with various levels internally and with customers
Strong communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
Excellent written, critical reading, effective problem solving, and oral communication skills
Ability to work independently, multi-task and thrive in fast-paced environment
Strong problem-solving skills including root cause failure analysis methods
Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities.
Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
Be aware of all relevant SOPs as per Company policy as they relate to this role
Able to comply with the company’s safety policy at all times
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.