Senior Quality Engineer

The Senior Complaints Quality Engineer will provide engineering support in post market surveillance, with a focus on complaint investigations, product evaluations, root cause and complaint trend analysis. The associate is responsible for planning and coordinating the daily complaint engineering activities and is accountable for managing the complaint engineers time efficiently and effectively to meet specific quality metrics related to complaints. The associate will advocate for the execution of initiatives & projects to enhance quality performance as part of Continuous Improvement. Job Details: Promote a work environment of continuous improvement that supports Client's Quality Policy, Quality System and Global Regulations. Function as the senior engineering complaint investigator. Perform decontamination and testing of returned devices. Perform data analysis, additional testing, simulation testing, and root cause investigations and resolutions in support of a thorough complaint investigation related to product quality and patient safety. Establish root cause failure analysis techniques, processes and test methods utilizing sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Document detailed product failure analyses in complaint records. Coordinate and host regularly scheduled reviews of post-market data. Participate in Quality Management Reviews as requested. Act as a mentor for complaint engineers. Responsible for timely and effective coordination and/or execution of assigned project activities. Define process improvements and implement solutions to improve the efficiency of post-market activities. Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions. Prepare responses to customers and field associates as necessary per process. Support internal and 3rd party audits with post-market related requests. Provide training and support for quality system processes and complaint engineering practices. QUALIFICATIONS: Background Experience Requires a minimum of a 4-year degree in Mechanical Engineering, Biomedical Engineering or equivalent discipline. Requires 8+ years increasing responsibility and experience in a medical device quality assurance environment. Prefer one to two years of auditor experience Working knowledge and understanding of FDA's QSRs, ISO 13485:2003, MDD, and other national/international regulatory quality system requirements. Knowledge, Skills and Abilities (KSAs) Post-Market quality engineering strongly preferred Background in GMP Quality and/or Medical Device Manufacturing ASQ Certified Quality Engineering (CQE) or similar ASQ certification Six Sigma green belt or problem-solving training (DMAIC) preferred Familiar with basic statistical tools, i.e. Minitab, average, standard deviation, process capability Proficient computer skills and demonstrated competence to include word-processing, database applications, and spreadsheet. Strong communication skills required Strong mechanical aptitude and methodical problem-solving Solid understanding of root cause analysis and different quality tools used to solve problems Mechanical aptitude skills for device building and/or test set-ups Demonstration of self-motivation and leadership skills Knowledge of Bio Hazardous Materials and related safeguards and protocols

Created: 2024-10-31