Sr Quality Engineer

 

Candidates who are applying must be residing within a 50-mile commutable distance from the job location. This is a hybrid position (3 days onsite) located at Exton, PA

 

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, the Senior Quality Engineer provides quality direction, governance, and Quality Management System best practices to syringe and drug containment programs.  This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment. 

This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets.  They will partner with R&D, Regulatory, Supplier Quality, Analytical Labs, Supply Chain, and Operations to ensure consistency across product platforms which promote development and manufacturing high volume efficiencies and ensure product platforms are compliant with regulatory and business requirements throughout the complete development lifecycle including commercialization, sustainment, and post market surveillance activities. 

The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. This role is also responsible for Quality oversight of documentation submitted to regulatory authorities in support of commercial launch and life-cycle management.

Essential Duties and Responsibilities

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Product Development, Risk Management, and Manufacturing:
  • Partner with R&D to provide Quality Engineering direction to multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements, ensuring sustainable and scalable solutions..
  • Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.) 
  • Oversee and provide direction to cross-functional teams on product development DHF/DMR documentation including but not limited to failure analyses, risk management activities, FMEAs (application, design and process), process flow analyses, design of experiments, process capability analyses, quality inspection procedures including sampling plans, and test method validation
  • Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures.
  • Partner with R&D to ensure successful design transfers of new or updated products and manufacturing transfers from Product Development into Manufacturing, in collaboration with Operations and third party providers.

Additional Responsibilities

• Quality Management System:
  • Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc.