Senior Principal Quality Assurance Engineer

2 weeks ago

Scottsdale, Arizona, United States West Pharmaceutical Services Full time

Job Overview

Ensure a secure working environment while adhering to quality standards and policies. Collaborate with business leaders to design, implement, and sustain programs that enhance solutions for the customer base. Deliver quality assurance support across all functions, emphasizing compliance with ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR) regulations. This position will facilitate the execution of complex projects that significantly influence product quality and compliance enhancements through the management of supplier-related items, validation processes, quality culture, risk management improvements, change management, material control enhancements, and quality control initiatives.

Key Responsibilities:

Engage with internal stakeholders and external regulatory agencies regarding compliance requirements as necessary. Aid in the preparation of quarterly Management Review meeting presentations. Participate in project team meetings regularly, providing support for validation and regulatory strategies across various initiatives. Review and authorize complaints, CAPA, audit findings, and non-conformance investigations to ensure thorough investigations are conducted. Develop and execute validation strategies, including writing technical reports as required. Create and implement validation protocols such as Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and/or Test Method Validations (TMV). Offer statistical guidance to ensure compliance across departments during design transfer processes, sampling plan implementations, establishment of Critical to Quality (CTQ) metrics, validation strategies, and investigations as needed. Continuously support the quality system by refining processes and systems, as well as updating and creating site or enterprise procedures, inspection requirements, and test method inspections. Participate in third-party audits (Notified Body, FDA, Customer) as required, serving in roles such as back room lead, subject matter expert, or reviewer. Manage key quality system programs, including CAPA, quality culture initiatives, and non-conformance programs, ensuring they are monitored and controlled. Provide assistance to manufacturing lines to resolve issues and escalate concerns to the non-conformance or CAPA processes as necessary. Collaborate on high-risk investigations to document resolutions for quality issues related to internal matters or external regulatory bodies through CAPA, SCAR, NCR, and audit findings, ensuring robust actions are taken to prevent recurrence. Supervise exempt and non-exempt personnel as needed. Mentor and train other Quality Engineers in engineering topics such as validation processes, root cause analysis, statistical techniques, SPC, CAPA, and NCRs. Escalate quality issues to senior management based on risk assessments and compliance evaluations. Ensure site metrics align with internal requirements and established goals. Work on complex projects to guarantee continuous process improvement. Develop strategies for high-complexity projects and ensure timely execution. Promote quality culture through initiatives and related processes. Provide coaching to engineers and auditors to foster a culture of development and process improvement. Adhere to all regulations, policies, work procedures, instructions, and safety rules. Maintain regular, reliable, punctual, and predictable attendance. Contribute to ongoing process improvement efforts aimed at reducing waste, cycle times, and enhancing efficiency and quality culture. Uphold a customer service mindset when interacting with internal and external customers while achieving production and quality standards. Keep a clean, organized, and safe workstation and environment at all times. Perform additional duties as assigned based on business needs.

Basic Qualifications:

Education or Equivalent Experience: Bachelor's Degree in Engineering or equivalent. Experience: 8-10 years of Quality Engineering experience. Knowledge of validation processes. Familiarity with medical device regulations and standards (ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR)). Project management skills.

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