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 presentation.
• Strong attention to detail and judgment when resolving quality and compliance issues.
• Excellent written and verbal communication skills.

Preferred qualifications:

• 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.

Requisition ID: 622792 

Minimum Salary: $ 78300 

Maximum Salary: $ 148800 

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 identity, 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.