Sr. Quality Assurance Specialist

RESPONSIBILITIES: Complaint Handling * Own and lead complaint initiation, investigation, and closure in compliance with regulatory requirements and internal procedures. * Perform root cause analyses and risk assessments to determine reportability, escalation, and corrective actions. * Trend and analyze complaint data to identify systemic issues and improvement opportunities. Nonconforming Material * Partner with Manufacturing and Engineering to resolve nonconformances and prevent recurrence. * Own Nonconforming Material Reports (NCMRs), including investigation, risk assessment, disposition decisions, and closure. Lot History Review * Perform and approve Lot History Record (LHR) reviews to support product release and investigations. CAPA * Escalate problems for possible corrective actions to manager. * Assist with CAPA investigations, root cause analysis, action planning, and effectiveness verification. * Ensure CAPA activities are timely and compliant with internal procedures. Document Control & Training * Review and release Engineering Change Orders (ECOs) into eQMS ensuring accuracy, traceability, and compliance. * Review controlled documents for compliance, clarity, and consistency. * Oversee training assignment and completion, assess training effectiveness and compliance. Supplier Quality * Assist with supplier qualification activities, including risk assessments, and documentation review. * Support supplier audits and corrective action activities. Audits * Serve as a QA SME during internal and external audits. * Ensure timely and effective closure of audit observations and nonconformances. Carry out all duties and responsibilities as assigned by the Company in accordance with Company policies, procedures, and applicable laws and regulations governing our business practices. EDUCATION REQUIREMENTS Bachelor's degree or equivalent required EXPERIENCE REQUIREMENTS Four-year college degree or equivalent combination of education and experience 5+ or more years' experience in a quality environment with an understanding of quality systems and processes Demonstrated experience leading complaint investigations and NCMRs Demonstrated experience reviewing and releasing approved ECOs into eQ Demonstrated experience assisting in CAPA investigations, audits, and supplier qualification Medical device experience or equivalent experience in a related field preferred OTHER QUALIFICATIONS Strong working knowledge of FDA 21 CFR 820, ISO 13485, and risk management principles Good verbal and written communication and interpersonal skills Strong root cause analysis and problem-solving skills. General proficiency in basic computer skills, including MS Office software suite, experience in quality management system software databases Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions Detail oriented with a focus on compliance with both internal and external requirements and an understanding of good manufacturing practices PHYSICAL DEMANDS Primarily encompasses work in office and laboratory environments with ability to sit or stand for long hours at a time, operating personal computers, inspection, measurement, and test equipment. Occasional handling of contaminated materials and decontamination chemicals. TRAVEL REQUIREMENTS Travel Requirements: 0 - 5% NOTE This is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, efforts, or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g., emergencies, changes in personnel, variation in workload, rush jobs, or technological developments).

Created: 2026-04-02