Principal Quality Engineer

Who We Are:

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

 

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 medium complexity projects that will impact the Quality of the product significantly throughout the implementation of changes involving supplier related items, validation process, Quality Culture, risk management process improvement, 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.
• Provide continued quality system support by improving processes and systems and by updating and creating site procedures.
• Participate in third party (Notified Body, FDA, Customer) audits as required.
• 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 within a CAPA, SCAR, NCR, Issue Review, Audit finding to ensure proper and robust actions are taken to eliminate re-occurrence.
• May supervise non-exempt personnel as required.
• May guide, coach, and train other Quality Engineers in Engineering topics such as Validation process, Root Cause Analysis, SPC, CAPA, NCRs, etc.
• Escalate Quality issues to upper management based on risk, trend, and compliance assessment.
• Ensure Site Metrics are complying with internal requirements and goals established.
• Work with medium complexity projects to ensure a process continuous improvement is in place.
• Create Medium Complexity Projects strategies and ensures execution is completed in a timely manner.
• May provide coaching to engineers/auditors to promote people development and process improvement culture.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Exhibits regular, reliable, punctual, and predictable attendance.

• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, quality culture reinforcement, and eliminate waste.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment always.
• Performs other duties as assigned based on business needs.

 

Basic Qualifications: 

 

• Education or Equivalent Experience: Engineering Bach