West Pharmaceutical Services · 1 day ago
Sr. Quality Engineer
US Puerto Rico Cidra
Full-time
Onsite
Senior Level
5+ years expWest Pharmaceutical Services is a company dedicated to improving patient lives through innovative healthcare solutions. The Sr. Quality Engineer oversees projects and maintains quality processes, addressing issues by analyzing outcomes and collaborating with teams for effective resolutions.
BiotechnologyIndustrialHealthcareManufacturingPharmaceuticalLogisticsHealth CarePackaging Services
Responsibilities
Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes
Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed
Independently performs supplier audits and corporate facility audits
Manage multiple project tasks and effectively coordinate handling of customer feedback and complaints
Lead assessment and closure of customer complaints, ensuring adherence to established procedures and documentation
Lead the evaluation and resolution of customer complaints, ensuring adherence to prescribed procedures and comprehensive documentation
Coordinate communication between internal teams and customers
Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication
Reviews, revises, and creates operating procedures to ensure compliance with all related external requirements, internal procedures or instructions, and the West Quality Manual
Ability to lead meetings with customers, employees and contractors as necessary to manage changes
Establishes monthly KPI’s and metrics to Quality Leadership
Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources
Review and approve laboratory procedures, work instructions, ESOPs, EWIs, PFNBs, protocols, forms, method transfers, reports, analyst analytical training, etc
Review all WSS documentation for compliance to West and/or Client policies and procedures, cGMPs and applicable ISO standards
Liaise and collaborate with the WSS departments/clients to initiate, investigate, review and approve OOS investigations and reports and any other lab investigations as deemed necessary
Conduct root cause analysis and issue appropriate corrective action when deemed necessary
Work/interface with Lab personnel for continuous improvements related to CAPA and/or customer or regulatory requirements
Plan, host and co-ordinate Customer, ISO, Corporate QA, and Regulatory audits/inspections of WSS facilities
Coordinate the responses to customer audit observations, customer complaints and request for information/documentation
Assure execution of internal quality audits, according to established procedures for the assigned areas / locations
Provide response to audit observations, and customer complaints and inquiries
Qualification
Required
Bachelor's Degree In Engineering or Science required
Minimum 5 years Experience in regulated Quality Assurance / Document/Configuration Control (or a formal education equivalent) required
Preferred
Master's Degree In Engineering or Science preferred
Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities preferred
Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820 preferred
Experience Leading Internal / External Audits, MasterControl, SAP and Share Point preferred
Experience with customer interface and meeting customer expectations preferred
Ability to work independently, multi-task and thrive in fast-paced environment
Excellent written and verbal communication skills
Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485
Familiarity with root cause analysis tools
Working knowledge of MasterControl and SAP
Support and contribute in Lean Sigma programs and activities towards delivery of the set target
Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members
Able to be aware of all relevant SOPs as per Company policy and Quality Manual
Able to comply with the company's safety policy at all times
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
Chairman, President, and CEO
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2026-02-05
2026-01-20
Company data provided by crunchbase