Job Description
We're a dedicated team at West, connected by a purpose to improve patient lives. Our story began with Herman O. West supplying penicillin to the US Government during WWII. We deliver life-saving medicines daily, and our impact on the healthcare industry has just begun. Join our inclusive community with opportunities for lifelong learning and growth. We support our team members' physical, mental, emotional, and financial health through benefit programs. We give back to the communities where we live and work and are committed to creating a healthier environment and planet through sustainability efforts.
**Job Summary:** The Senior Associate, Quality Assurance oversees projects, maintains processes, and addresses quality issues by analyzing outcomes and collaborating with teams for effective resolutions.
**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 perform 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 KPIs and metrics to Quality Leadership.
* Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources.
**Requirements:**
* Bachelor's Degree In Engineering or Science - required
* Master's Degree In Engineering or Science - preferred
* Minimum 5 years of experience as Sr Associate is required
* Experience in regulated Quality Assurance / Document/Configuration Control (or a formal education equivalent)
* Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities
* Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820
* Experience Leading Internal / External Audits, MasterControl, SAP and Share Point
* Experience with customer interface and meeting customer expectations.
**Preferred Knowledge, Skills and Abilities:**
* Ability to work independently, multi-task, and thrive in a 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.
**Additional Requirements:**
* 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.
* 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.
* Maintain high attention to detail, accuracy, and overall quality of work.
* Effectively communicate and interface with various levels internally and with customers.
* Able to be aware of all relevant SOPs as per Company policy and Quality Manual.
**Equal Opportunity Employer:** 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 removed email address.