Boston Scientific · 19 hours ago
Senior Clinical Quality Assurance Specialist- PQS Vendor Management
US-MN-Maple Grove
Full-time
Hybrid
Mid, Senior Level
$78K/yr - $149K/yr
3+ years expBoston Scientific is a leader in medical science dedicated to solving health industry challenges. The Senior Clinical Quality Assurance Specialist will drive improvement and corrective actions in clinical quality for services provided by outside vendors, while providing technical and audit support in the selection, qualification, and assessment of clinical vendors.
Health CareMedicalMedical Device
No H1B
Responsibilities
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
Qualification
Required
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
Preferred
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
Have Boston Scientific Vendor management experience
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
Benefits
Variable compensation from time to time (e.g., any overtime and shift differential)
Annual bonus target (subject to plan eligibility and other requirements)
Long-term incentives (subject to plan eligibility and other requirements)
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
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