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Senior Principal Quality Assurance Engineer

2 months ago

Scottsdale, Arizona, United States West Pharmaceutical Services Full time

Job Overview

Ensure a secure working environment while upholding quality standards and regulations. Collaborate with business leaders to design, implement, and sustain programs that enhance solutions for our clientele. Provide quality assurance support across all departments, focusing on 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 changes, validation processes, quality culture, risk management improvements, change management, material control enhancements, and quality control initiatives.

Key Responsibilities:

  • Engage with internal teams and external regulatory agencies regarding compliance requirements as necessary.
  • Assist in preparing presentations for quarterly Management Review meetings.
  • Regularly attend project team meetings, providing support for validation and regulatory strategies across various initiatives.
  • Review and approve investigations related to complaints, CAPA, audit findings, and non-conformances to ensure thorough and effective resolutions.
  • Develop and execute validation strategies, including the creation of technical reports as required.
  • Design and implement validation protocols such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and/or Test Method Validations (TMV).
  • Support the site with statistical techniques to ensure compliance across departments during design transfers, sampling plan implementations, establishment of Critical to Quality (CTQ) metrics, validation strategies, and necessary investigations.
  • Enhance quality systems by refining processes and updating or creating site and enterprise procedures, inspection requirements, and test method inspections.
  • Participate in third-party audits (Notified Body, FDA, Customer) as required, serving as a back room lead, subject matter expert, or reviewer.
  • Manage key quality system programs such as CAPA, quality culture initiatives, and non-conformance programs, ensuring they are monitored and controlled.
  • Provide support to manufacturing operations to address quality issues and escalate them through the non-conformance or CAPA processes as needed.
  • Document resolutions for high-risk investigations involving quality issues with internal and external stakeholders through CAPA, SCAR, NCR, and audit findings to ensure robust corrective actions are implemented.
  • Supervise exempt and non-exempt personnel as necessary.
  • Guide, coach, and train other Quality Engineers on topics such as validation processes, root cause analysis, statistical techniques, SPC, CAPA, and NCRs.
  • Escalate quality concerns to senior management based on risk assessments and compliance evaluations.
  • Ensure site metrics align with internal requirements and established goals.
  • Work on high-complexity projects to maintain continuous process improvement.
  • Create strategies for high-complexity projects and ensure timely execution.
  • Drive initiatives to reinforce quality culture through related activities and processes.
  • Provide coaching to engineers and auditors to foster a culture of development and process improvement.
  • Adhere to all regulations, policies, procedures, and safety protocols.
  • Exhibit reliable and punctual attendance.
  • Contribute to ongoing process improvement efforts aimed at reducing waste, cycle times, and enhancing efficiency and quality culture.
  • Maintain a customer service-oriented approach when interacting with internal and external clients while fulfilling work and quality standards.
  • Keep a clean, organized, and safe work environment at all times.
  • Perform additional duties as assigned based on business needs.

Basic Qualifications:

  • Education: Bachelor's Degree in Engineering or equivalent.
  • Experience: 8-10 years in Quality Engineering.
  • 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 experience.