West Pharmaceutical Services · 1 day ago
Senior Quality Engineer
Rockford, IL
Full-time
Onsite
Senior Level
5+ years expWest Pharmaceutical Services is a dedicated team focused on improving patient lives through innovative healthcare solutions. The Senior Quality Engineer will provide quality direction and governance across multiple projects, ensuring regulatory compliance and overseeing quality management systems throughout the product development lifecycle.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
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
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
Qualification
Required
Bachelor's Degree in Engineering or Science or equivalent experience required
Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities required
Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required
In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971 required
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
Preferred
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
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
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
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
President, CEO and Chair of the Board
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2025-12-06
Company data provided by crunchbase