Senior Clinical Quality Assurance Specialist

Additional Location(s): 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:

The Sr Clinical Quality Assurance Specialist assists the Manager, Clinical QA, with internal quality assurance program for the assigned business area.  Serves as clinical QA representative on clinical project teams and conducts internal and external quality audits to ensure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures. Supports Inspection Readiness, Clinical Corrective and Preventative Action (CAPA) and acquisition integration.

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 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

 Quality system responsibilities:

• 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.

Required qualifications:

• Bachelor’s degree in Science, Health, or Engineering or a relevant field of expertise
• 5-7 years of work experience with quality systems/controlled processes
• Ability to travel up 30%

Preferred qualifications:

• Auditing experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines or equivalent relevant experience
• Working knowledge of US and International regulations and standards applicable to BSC
• Working knowledge of ISO 14155, GCP
• Additional quality certifications from ASQ, SOCRA, RQAP-GCP, etc.
• Experience working cross-functionally with multiple stakeholders

Requisition ID: 606578 

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 www.bscbenefitsconnect.com--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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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.