Shire Jobs

Job Title: Engineer, QualityReports To: Supervisor, QualityPosition Location: Buffalo, NYFLSA Status (Exempt/Non-Exempt): ExemptPosition Summary: As a Quality Engineer in the Diagnostics division, you will play a crucial role in ensuring the quality and compliance of our diagnostic products throughout their lifecycle. You will collaborate closely with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, and Product Management, to develop and maintain robust quality systems and processes. Your efforts will directly impact the accuracy, reliability, and safety of our diagnostic solutions, ultimately contributing to the enhancement of patient care.Responsibilities:Collaborate with R&D and Manufacturing teams during product development and manufacturing processes to ensure quality standards are met from design to production.Perform risk assessments and analysis to identify potential quality issues and implement effective preventive and corrective actions.Develop and maintain quality control procedures, specifications, and inspection processes to ensure compliance with regulatory requirements and industry standards.Lead or participate in the investigation of non-conformances, customer complaints, and product failures, identifying root causes and implementing corrective and preventive actions.Conduct internal audits and assessments to evaluate the effectiveness of quality systems, identifying areas for improvement and driving continuous improvement initiatives.Assist in the development and implementation of validation protocols and procedures for equipment, processes, and software systems.Collaborate with Regulatory Affairs to ensure product quality documentation is prepared and maintained for regulatory submissions and audits.Provide guidance and training to employees on quality standards, processes, and regulations to enhance overall awareness and adherence to quality requirements.Monitor industry trends, regulatory changes, and best practices related to quality assurance and recommend appropriate actions to maintain compliance and competitiveness.Qualifications:Bachelor's degree in Engineering, Biotechnology, or a related Life Sciences field; Master's degree preferred.Proven experience (5 years) as a Quality Engineer or Technician in the biotech, medical device, diagnostics or other FDA regulated industry. Strong understanding of quality management systems (ISO 13485, 21 CFR Part 820 ) and relevant regulatory standards.Experience with risk management methodologies (e.g., FMEA) and statistical tools for quality analysis.Knowledge of diagnostic technologies, assay development, and validation processes.Excellent problem-solving skills with a detail-oriented and analytical approach.Effective communication skills to collaborate with cross-functional teams and present findings clearly.Certification in quality management (e.g., ASQ-CQE) is a plus.Experience working within an FDA recognized electronic QMS such as Master Control preferred. This position has not been approved for Relocation Assistance.The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

Minimum Salary: 55000 Maximum Salary: 70000 Salary Unit: Yearly