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Principal Clinical Quality Assurance Specialist (Remote) Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote Global
Onsite Location(s): 

Arden Hills, MN, US, 55112

Additional Location(s): US-MA-Marlborough; US-AZ-Phoenix; US-CA-Los Angeles; US-CA-Sacramento; US-CT-Hartford; US-FL-Orlando; US-GA-Atlanta; US-IA-Central/Des Moines; US-IL-Chicago; US-IN-Indianapolis; US-MA-Boston; US-MD-Baltimore; US-MI-Detroit; US-NC-Raleigh/Durham; US-NY-New York City; US-PA-Philadelphia; US-PA-Pittsburgh; US-RI-Providence; US-TN-Memphis; US-TX-Austin; US-TX-Dallas; US-TX-Houston; US-UT-Salt Lake City; US-WA-Seattle; US-WI-Milwaukee

 

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.

 

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Our Rhythm Management Clinical Quality Assurance team rigorously pursues adherence to good clinical practice within some of the most challenging clinical device trials conducted in pursuit of transforming lives with groundbreaking technologies that address irregular heart rhythms, heart failure and sudden cardiac arrest.

 

We are seeking an engaging and qualified Principal Clinical Quality Assurance Specialist who is aligned with our core values that define Boston Scientific culture and empower our employees: Caring - Meaningful innovation - High performance - Global collaboration - Diversity - Winning spirit.  Because a career with Boston Scientific is more than just a job. It’s personal. We’re committed to solving some of healthcare’s toughest problems – united by a deep caring for human life. If you’re a natural problem-solver with the imagination, courage, and spirit to make a meaningful difference in clinical quality, there’s no better place to build your career.

 

This is a remote position supporting a global Clinical team conducting investigational device trials at global sites.  Qualified US and OUS candidates are encouraged to apply.

 

Your responsibilities will include:

 

Clinical Compliance - Hands-on partnership with Clinical for clinical quality consultation and inspection readiness:

  • Provides clinical quality representation on clinical trial project teams to always foster and inspire clinical teams towards a state of inspection readiness
  • Provides support and response to compliance and regulation questions including quality review of clinical study documents and related functional study plans
  • Supports Inspection Readiness program to include inspection readiness training and coordination/participation in Mock BIMO inspections as well as external inspections
  • Communicates with global clinical teams and Strategic Sourcing regarding clinical vendors, new clinical vendor requests, current clinical vendor needs, and future needs

 

Independent Auditing:

  • Creates risk-based study audit plans; plans, schedules, and conducts internal clinical quality audits, clinical process audits, investigator site audits, and clinical vendor audits to assure BSC clinical investigational trials and post market studies comply with applicable regulatory requirements, quality and GCP standards, and BSC policies and procedures
  • Documents and communicates audit observations; evaluates impact and makes recommendations for corrections and/or corrective actions. Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated and completed
  • Keeps abreast of and interprets current worldwide regulatory requirements; advises various stakeholders regarding possible ramifications of regulatory changes 

 

Clinical Quality System: Support to the Clinical organization in meeting BSC Quality system requirements

  • Supports Clinical and QS team during External Regulatory/Notified Body audits
  • Supports the CAPA program, providing quality input for assessing internal noncompliance and recommending initiation of corrections/CAPAs, working closely with Clinical CAPA team and CAPA owners through to successful closure
  • Participates on clinical process improvement projects and initiatives
  • Provides review and comment to relevant BSC procedure revisions
  • Supports departmental, divisional, and corporate quality goals and priorities 
  • Initiates and/or collaborates on continuous improvement projects related to the BSC Clinical Quality Management System.

 

Acquisition integration:

  • Represents Clinical Quality on clinical acquisition/integration teams for identification, assessment, and mitigation of risks associated with the transfer of sponsorship of clinical studies from acquired entities, supporting development and execution of a clinical integration plan, transfer of quality systems, and compliance to GCP and applicable regulations with aim to ensure subject safety and integrity of study data.

 

What we're looking for in you: 

 

Minimum Qualifications:

  • Minimum of a bachelor’s degree with minimum of 8 years’ experience in the medical device, pharmaceutical, or other industry in an area regulated by GCP regulations and guidelines; OR in the alternative, a life science or Nursing Associate Degree with active Registered Nurse licensure and at least 12 years of relevant experience
  • Demonstrated clinical research audit experience with one or more of the following: clinical trial primary research coordinator, GCP lead auditor, CAPA leader, research compliance, and clinical research SOP author
  • Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance
  • Working knowledge of regulations, standards, paper and electronic Good Documentation Practices, and privacy/security obligations relevant to conducting IDE Trials, including 21 CFR (50, 54, 56, 812, Part 11), GCP (ISO14155:2020 and/or ICH E6 R2), HIPAA and GDPR
  • Independent, reliable, professional, collaborative, team player aligned with BSC mission, vision, and culture goals
  • Demonstrated experience with complex verbal and written communication to a variety of stakeholders, as well as successful conflict resolution skills
  • Strong electronic system adopter/user with understanding of system user access controls and workflow validations process
  • Ability to travel domestically and internationally up to 30%

 

Preferred Qualifications:

  • RAQP-GCP/ SoCRA or ACRP certification or equivalent
  • Experience with maintaining compliance to medical device manufacturer quality system or other clinical quality system requirements
  • EU CA, Health Canada, PMDA, CFDA experience 
  • 5 or more years of direct clinical quality (GCP) auditing experience
  • Knowledge of EU MDR
  • Non-English language(s) proficiency for reliable verbal and written audit related reviews and communication with EU investigational sites (Germany, Italy, Spain)
  • Demonstrated experience communicating with all levels of the organization

 

Requisition ID: 538458

 

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 is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 

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.

 

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