Title:  Senior Quality Specialist

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

Supports all quality system and functions. Assists in establishing systems to support the facility to drive continuous improvements and minimize the costs of non-conformance. Plans, schedules, executes, and communicates all items regarding quality issues, quality records, validations, and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMPs.

Essential Duties and Responsibilities:

• Participates in ISO and corporate quality system audits (internal/external).
• Leads and assists in investigation of OOSs, CAPAs and deviations as necessary to identify and find the root cause of all product and related quality issues.
• Provides expertise and guidance to site personnel in usage of root cause analysis tools for investigations/continuous improvements.
• Assists with process, documents, procedures, and forms changes as needed.
• Maintains spreadsheets and trackers for different quality records.
• Ability to consistently maintain metrics for quality records.
• Assumes responsibility for various assigned projects designed to improve product quality, quality management systems processes, reduce costs and/or validate facility products or processes.
• Maintains and reports information on statistics on facility quality performance, including Cost of Quality data.
• Fills in for Quality Manager as requested or required.
• Promotes and supports a Lean environment within the facility.
• Performs other duties as required and/or assigned.

Basic Qualifications: 

• Bachelor’s
• Emphasis in science or engineering, or related combination of experience, education.
• 3-5 years of experience working in the medical device industry or other FDA regulated industry
• Knowledge of and experience working with ISO 13485, FDA CFR 21 820 or other FDA regulated industry.
• Experience developing SOPs (Standard Operating Procedures) to comply with the medical device regulations or other FDA regulated industries.Experience leading or participating in audits

Preferred Knowledge, Skills and Abilities:

• Knowledge of Six Sigma tools and Lean techniques
• ASQ CQA certification or equivalent
• Demonstrates problem solving and planning/organizing skills
• Demonstrated proficiency in MS Office products (Project, Word, Outlook, Excel)
• Working knowledge of Power BI and DevOps
• Able to communicate effectively with clear, concise, and organized information, both
• verbally and in writing.

Travel Requirements:

• Minimal.

Physical and Mental Requirements:

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.  
• Must be able to work overtime as required to support audit days.
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.   
• Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.   
• Must be able to understand direction and adhere to established policies and procedures. 
• Must be able to multitask and adapt while working in a fast-paced environment.

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 Apply.Accommodation@westpharma.com.  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 and/or a pre-employment drug screening.