Quality Engineer

This is a fully onsite role requiring team members to be onsite 5 days a week. No relocation is provided for this opportunity.    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

Plan, schedule, execute & communicate all items regarding quality issues, complaints, validations & other projects to QA Manager and/or other interested parties. Provide technical assistance for developing and maintaining measurement routines for the various vision measuring system. Provide quality assistance in support of new product development and validation. Support customer complaint process. Provide quality assistance including SPC support with facility manufacturing, engineering, maintenance, shipping and warehouse functions. Be a quality resource in the improvement of all aspects of plant operations and in the plant’s relations with its customers and suppliers. Perform all duties associated with the auditing and documentation of compliance related items against ISO standards. Essential Duties and Responsibilities

Assisting facility and design development personnel as needed for engineering/projects. Providing guidance and training to all QA personnel about new operation and programming of vision system equipment. Providing backup support to QA Manager and/or QA Supervisor, as needed. Assisting in the investigation of customer complaints to ensure timely response. Assisting in maintenance and improvement of facility required quality systems including ISO 13485 and HACCP. As required, work with Manufacturing, Engineering, Sales, the Customers and Suppliers to resolve issues on new products.  (This may require travel.)

Become knowledgeable in all areas of the Q.A. Department and work with the various functions within Q.A. to resolve internal issues as they arise. Perform audits of the various departments / functions as directed by the Q. A. Manager. As required, participate and or lead Customer meetings / audits, Supplier meetings / audits and corporate audits. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventative actions to preclude recurrence (CAPA). Ability to closely interact with customers to understand and integrate those requirements into West manufacturing and quality system requirements Work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any necessary records for filing tooling product history files Complete dimensional analysis for OQ & PQ as needed to include capability, normality and transformation of data when required. Create validation protocols (IQ, OQ & PQ) and obtain customer approval, when applicable. Complete validation reports and submit to internal and external teams as applicable. Aid in validating and reviewing validations of equipment, products and