Senior Clinical Quality Assurance Specialist- PQS Vendor Management

Your responsibilities will include: Assist in generating study-specific component specifications. Provide input to Design Engineering on new component technology and assist with quality and reliability analysis. Analyze incoming material defects, manage disposition, drive corrective actions, and communicate supplier issues. Investigate field failures related to supplier materials and develop corrective action plans. Participate in or lead vendor audits to determine GLP compliance and qualify vendors. Collaborate in the development of departmental SOPs, work instructions, templates, and forms. Participate in project teams and advise on GLP compliance issues. Perform document coordinator functions (e.g., maintain index, track review cycles, archive control records). Minimum Bachelors degree or Associates degree with 3 years of professional experience 1+ Year of auditing experience 3+ years Experience in FDA regulated environment (Pharmaceutical, Medical Device, Biologics) Have Clinical or Quality experience Willing to travel as needed up to 25-30% within US and/or international Solid knowledge of technical and functional principles within quality assurance. Experience assessing vendors and managing qualification documentation under PQS. Familiarity with GLP regulations and clinical audit processes. Ability to influence decision-making through data organization and presentation. Strong attention to detail and judgment when resolving quality and compliance issues. Excellent written and verbal communication skills. Bachelors degree with 3 years of professional experience conducting vendor audits Experience in Pharmaceuticals and/or Biologics in addition to Medical device Have Clinical Quality experience Experience working with CRO, clinical vendors Prior experience working with cross-functional clinical teams and external vendors. Background in medical device, pharmaceutical, or biologics industries. Experience managing global vendor lists and audit tracking systems. Knowledge of component testing, validation, and quality engineering processes.