Sr Principal 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:

 

Maintain a safe work environment and ensure compliance with quality objectives and policies. Work with business leads to develop, implement, and maintain programs and enhance solutions for customer base. Provide quality assurance support to all functions with focus on compliance in accordance with ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR) requirements. This role will support the execution of high complexity/impact projects that will impact the Quality of the product and a Compliance improvement significantly throughout the implementation of changes involving supplier related items, validation process, Quality Culture, risk management process improvement, change management, material controls improvement and Quality Control items.

 

Essential Duties and Responsibilities:

 

• Interface with internal constituents and external regulatory bodies regarding compliance needs as required
• Assist in the preparation of the Management Review meeting presentations on a quarterly basis.
• Attend project team meetings on a regular basis and provide assistance with validation and regulatory strategies for various projects.
• May review and approve Complaint, CAPA, Audit Findings, Issue Reviews, Non-conformances investigations to provide guidance to ensure effective investigations are completed.
• Prepare Validation Strategies and executes accordingly by writing technical reports as needed.
• May create and execute validation protocols such as IQs, OQs, PQs, and/or TMVs.
• Supports the site with statistical techniques guidance to ensure compliance at the different departments during design transfer process, sampling plan implementations or improvements, establishments of CTQs, Validation strategies, and investigations as required.
• Provide continued quality system support by improving processes and systems and by updating and creating site procedures or enterprise procedures, Inspection requirements, Test Method inspections, etc.
• Participate in third party (Notified Body, FDA, Customer) audits as required: Back room lead, SME, Reviewer, etc.
• May manage key quality system programs such as CAPA, Quality Culture initiatives, Non-conformance or other QMS elements programs that are to be monitored and under control.
• Provide support to manufacturing lines to address issues and escalate issues to NC or CAPA process as needed.
• May work with high-risk investigation to document Quality Issues resolutions involved with internal issues or customer and external regulatory bodies through CAPA, SCAR, NCR, Issue Review, External Audit findings (Regulatory bodies: FDA, DEKRA, SGS) to ensure proper and robust actions are taken to eliminate re-occurrence.
• May supervise exempt and non-exempt personnel as required.
• Provide guidance, coaching, and train other Quality Engineers in Engineering topics such as Validation process, Root Cause Analysis, Statistical techniques, SPC, CAPA, NCRs, etc.
• Escalate Quality issues to upper management based on risk, trend, and compliance assessment.
• Ensure Site Metrics are complying with in