Senior Clinical Quality Assurance Specialist- PQS Vendor Management

Additional Location(s): Ireland-Cork; US-MA-Marlborough; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role:
This position drives improvement and corrective actions in clinical quality for services provided by outside vendors and service providers. The Senior Quality Assurance Specialist provides technical and audit support in the selection, qualification, and periodic assessment of clinical vendors under the Pharmaceutical Quality System (PQS). The role also includes preparing and managing clinical vendor services documentation to support regulatory readiness and successful inspections.

Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Assess potential new clinical service vendors for clinical services and their quality capabilities.
• Maintain all clinical vendor files and assessments within the global clinical Approved Vendor List (cAVL) for PQS.
• Write and revise clinical vendor management procedures in collaboration with Clinical functional teams, Sourcing, and Clinical Supply Chain.
• Assist in generating study-specific component specifications.
• Generate test protocols, monitor testing, issue qualification test reports, and approve components for use.
• 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.
• Review new design specifications from a component quality and manufacturability perspective.
• Investigate field failures related to supplier materials and develop corrective action plans.
• Review or audit study and validation-related documentation (e.g., protocols, critical phase inspections, data audits, method/software validation audits). Issue audit statements as appropriate.
• Participate in or lead vendor audits to determine GLP compliance and qualify vendors.
• Write and distribute audit reports; enter audit data into databases and maintain audit records per SOPs.
• Track audit findings and corrective actions, and document completion.
• Collaborate in the development of departmental SOPs, work instructions, templates, and forms.
• Participate in project teams and advise on GLP compliance issues.
• Lead or support departmental projects and initiatives.
• Perform document coordinator functions (e.g., maintain index, track review cycles, archive control records).
• Demonstrate a primary commitment to patient safety and product quality by ensuring compliance with the Quality Policy and all documented quality processes and procedures.

Qualifications:

Required qualifications:

• 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 presen