Title:  Quality Engineer

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 you will plan, schedule, execute & communicate all items regarding quality issues, complaints, validations & other projects to QA Manager and/or other interested parties. .  Participate in steering committees which originate from both corporate and manufacturing facilities.  Support customer complaint data acquisition, root cause analysis and draft complaint responses.  Performs all duties associated with compliance-related items for ISO standards and cGMps.

Essential Duties and Responsibilities:

• Support site Quality Engineers/Quality Specialists in meeting customer expectations in complaint investigation responses. Aid in assuring expected turn-around time metric is attained.
• Assist in developing site Quality Engineer staff in usage of tools and processes for customer complaint investigations/continuous improvement.
• Analyze data, process capabilities, customer concerns and expectations and any other leading or lagging indicators which may be used to improve product and process knowledge.
• Interact with customers to understand and integrate those requirements into West manufacturing and quality system requirements.
• Meet company and departmental goals in the continuous improvement of all products, services, and processes.
• Support quality assurance improvement activities by evaluating products, processes, or materials to develop control or improvement strategies intended to improve the customer’s experience.
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.
• Assists facility with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques.
• 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 SPC programs.
• Perform internal ISO and quality systems audits in accordance with ISO standards including recommending ways to resolve any issues identified in the audit findings.
• Supports 2nd and 3rd Party Audits as required.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

Basic Qualifications:      

• Bachelor’s degree in engineering or related field Required             
• Required experience with Project Management tools and able to provide support and contribute in Lean Sigma programs and activities towards delivery of the set target               Preferred            
• Preferred Knowledge, Skills and Abilities
• Able to interface with customers and meeting customer expectations.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

Physical 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.

Additional Requirements:

• Need to have extreme attention to detail.
• Ability to work in an office and/or manufacturing environment. May need to stand or sit for extended periods of time.
• Medical component and device manufacturing require strict adherence to standards. Must be able to tolerate fumes and from various manufacturing processes, also subject to heat and cold, as well as loud noise.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams.
• Use written and oral communication skills.
• Read and interpret data, information, and documents.
• 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.

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.