Sr. Clinical QA Specialist

Recruiter: Spencer Gregory Hale

Sr. Clinical QA Specialist

About the role:

Assists the Manager, Clinical QA, with internal quality assurance program for the Interventional Cardiology (IC) Business unit. This role ensures clinical trial compliance and inspection readiness by assessing protocol, GCP, and regulatory adherence, evaluating data quality, and supporting issue resolution. It contributes to audit planning, NCEP/CAPA/SCAR processes, and regulatory inspection preparation. The role collaborates cross-functionally to address nonconformances, perform root cause analysis, and verify corrective actions. It supports IC Clinical Quality Assurance activities, communicates quality signals, and drives continuous improvement. Additionally, it helps develop and maintain global quality systems to enhance compliance and proactively advises on regulatory changes.

Your responsibilities will include:

• Participates in clinical project teams, and always influences clinical teams toward a state of inspection readiness

• Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials

• Assesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures

• Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials

• Participates in problem-solving with clinical project teams at investigator sites

• Communicate observations to clinical investigators and clinical program managers

• Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed

• Ensures tracking of audit findings

• Contributes to the development of audit procedures and processes

• Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives

• Assists in the preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings

• Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes

• Support the Clinical organization in meeting BSC Quality system requirements

• Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners and providing quality input

• Partner with Clinical to support supplier and BSC-related nonconformances by performing the following activities (NCEP, CAPA, SCARS):

• Conduct root cause analysis

• Determine corrective and preventive actions

• Determine verification of effectiveness actions to support the corrective and preventive actions

• Support IC CQA portfolio activities and quality system deliverables for IC CQA, including but not limited to quarterly audit schedule updates, management of IC CQA surveillance activities, communication of quality signals to quality leads and clinical leadership, and coordination of clinical and clinical quality QMR deliverables for ICTx and WM. 

• Proactively drive clinical compliance, making data-driven decisions to facilitate process improvement and a proactive quality culture.

• Participates in the development, implementation, and maintenance of global quality systems. Works to identify ways to improve compliance with regulations and BSC policies and procedures for CQA

Quality System Requirements:

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

• Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.

• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

What we're looking for in you:

Required Qualifications:

• Bachelor’s degree in science, health, engineering or a relevant field of expertise

• 5-7 years of work experience with quality systems/controlled processes

• Previous experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines

• Strong presentation, communication, and critical thinking skills

• Strong understanding of Quality Systems

• Working knowledge of ISO 14155 and GCP

• Working knowledge of ISO 13485

• NCEP, CAPA, and Supplier Corrective Action experience

Preferred qualifications :

• Working knowledge of US and International regulations and standards applicable to BSC

• Additional quality certifications from ASQ, SOCRA, RQAP-GCP, etc.

• Experience working cross-functionally with multiple stakeholders

• NCEP, CAPA, and Supplier Corrective Action experience

• Ability to collaborate and influence across multiple, cross-functional teams

Requisition ID: 612660 

Minimum Salary: $ 86600

Maximum Salary: $ 164500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.