Senior 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, the incumbent will lead and support projects affecting the Kinston site on the part of the quality department using appropriate project management tools.  The incumbent will manage projects by following the West Quality goals in order to meet customer expectations. 

 

Essential Duties and Responsibilities

• Coordination of product transfers between West plants including documentation, coordination of trials and round robin studies, root cause analysis in case of differences detected.

• Initiating, Leading/ Supporting projects (Quality improvement, automation, and R+D projects) using established project management tools.

• QA support for plant and global projects including technical consultancy with respect to approach, structure and implementation strategies

• Support and Management of risk analysis and initiation of risk mitigation and corrective actions.

• Data collection, evaluation and trending of quality-relevant measurements.

• Creation of annual product reviews including data analysis and CAPA management

• Support of internal and external project such as improvement projects, automations, and transfer from a quality point of view.

• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.

• Responsible 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 Statistical Process Control programs.

• Perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols, and identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed.

• Other duties as assigned.

Education

• Bachelor's Degree in Engineering or Science or equivalent experience required

Work Experience

• Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities required and
• Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required and
• In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971 required and
• Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required and

Preferred Knowledge, Skills and Abilities

• Experience with MasterControl, SAP, Share Point, Teamcenter
• Experience with ISO 11040, ISO 11607
• Expertise in quality management to