Quality Engineer

Description This is an onsite position requiring the team member to be onsite 5 days a week Who We Are 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 be a hands-on contributor to West’s success and culture of continuous improvement. You will be directly involved in measuring and analyzing data, implementing corrective actions, and improving products, services, and processes. A significant amount of your workday will be spent in the production and QC areas. Another key component of this position is supporting cross-functional corrective actions and continuous improvement projects in QA/QC, Process Engineering, and Production, at the site, intra-site and corporate levels.

Essential Duties And Responsibilities

• Drive improvement of site and departmental goals of Cost of Poor Quality, Yield Opportunity, etc.
• Provide quality reports and review trending on assigned areas of responsibility
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence
• Support and contribute to Lean Six Sigma programs and activities towards delivery of the set targets, and continuous improvement of products, services, and processes
• Participate in the development and maintenance of product/service/process risk and hazard analysis
• Conduct Quality Shop Floor Audits to identify, communicate, and follow-up on issues that may impact product quality
• Support optical measurement equipment and systems
• Other duties as assigned

Education

• Bachelor's Degree in Engineering, Biology, or Business or equivalent experience required

Work Experience

• Minimum of 3 years experience in a Quality or Engineering role at a pharmaceutical, medical device, or other regulated manufacturer

Preferred Knowledge, Skills And Abilities

• Knowledge of Lean, Six Sigma, DMAIC, PDCA, Root Cause Analysis, Corrective Action, Problem Solving
• Experience with statistical processing software (Minitab highly preferred)
• Experience with programming and/or operation of CNC machine tools or CMMs
• Experience with Material or Enterprise Resource Planning (MRP or ERP) system (SAP highly preferred)
• Knowledge of ISO 9001, ISO 13485 or 15378, 21 CFR 820, 21 CFR 210 & 211, cGMP
• Experience auditing processes and products
• Ability to read and interpret technical drawings and documents
• Demonstrate personal initiative and accountability by proposing creative and innovative solutions while actively driving improvement activities forward
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times
• Able to be aware of all relevant SOPs and Company policies related to duties in this Job Description

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification Upon Hire preferred and
• Manufacturing\Lean Six Sigma Black Belt with DOE experience. Upon Hire preferred

Travel Requirements 10%: Up to 26 business days per year

Physical Requirements Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.

Additional Requirements

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• 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.
• Use written and verbal communication skills to all levels of the organization
• Read and interpret data, information and documents
• Analyze and solve problems
• Observe and interpret situations
• Learn and apply new information or new skills
• Work under deadlines with constant interruptions

What We Offer Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.

Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.

Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.

This is an onsite position requiring the team member to be onsite 5 days per week

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 [email protected] . 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.