Principal Quality Compliance Analyst

Additional Location(s):  N/A; US-MA-Marlborough; US-MN-Arden Hills; 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 Principal Quality Compliance Analyst identifies, develops, establishes, maintains, and improves quality systems methodologies, systems, and practices which meet BSC, NMD, customer, and regulatory requirements. Serves as key Quality representative to improve awareness, visibility, and communication on quality system initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality systems compliance support within new product development, operational, or system/services support. Demonstrates great aptitude in interpreting and applying external quality system management regulations and standards.  Works closely with Med Safety to support Health Hazard Assessments, works with Product Performance Engineers and Risk SMEs to support risk management files/updates/changes as it pertains to PIRs/CAPA support.

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.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Supports Quality System PIR and Field Action sub-process through managing and supporting the PIR/FA process
• Maintains collaborative relationship with Regulatory Agencies, specifically FDA.
• Authors, executes, and supports all aspects of Field Action documentation working closely with Post Market Communication team, regulatory and Field Actions teams.
• Identifies, develops, establishes, maintains, and improves quality systems methodologies, systems, and practices which meet company and regulatory requirements.
• Serves as an expert-level Quality representative to improve awareness, visibility, and communication on quality system initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
• Provides focused quality systems compliance expertise within product development, operational, or system/services support.
• Advanced-level aptitude in interpreting and applying external quality system management regulations and standards. 
• Provides project direction, coaching, and mentoring for quality system personnel at all levels of the organization.
• Bridge the gap on the Global vs local Quality System documentation by proactive review and assessment.
• Drives improvement within the organization as well as global level improvement and changes to support QMS, CAPA, PIR etc
• Supports the development team on strategy and compliance around, new product development, sustaining and HFA (Human Feasibility Assessment studies.
• Supports the organization by combing the business needs with compliance and setting the right strategy for success.
• Assesses local and global processes and establishes the most efficient path to drive the organization forward.
• Works as a liaison between Med Safety and PIR team, by working with the CIS team to drive data as needed to support complex CAPAs or PIR activities
• Works with CAPA team to support and drive risk evaluations and updates
• Is responsible for CAPA sign off for all CAPA resulting from PIRs

Required qualifications:

• Bachelor’s of science degree
• Minimum of 8 years relevant experience, preferably in medical device industry
• Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management:  21 CFR Part 820, ISO 13485, AIMDD, MDD, MHLW, MDR SOR/98-282, 21 CFR Part 211, ISO 14971
• Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements
• Excellent verbal / written communication, interpersonal, project management, and organizational skills; must be able to multi-task, and analyze information quickly
  • Ability to communicate with all levels of the organization
• Must be able to work independently, lead and / or participate as part of a team
• Must be proactive, work independently, and be a contributing member of a highly visible team
• Must have working knowledge of Medical device product development cycle
• Must have experience working on NCEPs and CAPAs

Preferred qualifications:

• Master’s degree and 5+ years relevant experience, preferably in medical device industry or other regulated industry
• Experience working on PIRs or evaluations supporting field action decisions
• Prior experience working on Class III medical device projects
• Prior experience working on HFA (Human Feasibility Assessment) projects
• Prior experience leading teams on complex CAPAs
• Prior experience interfacing with auditors or investigators directly, supporting Quality System audits

Requisition ID: 600391

Minimum Salary: $103700 

Maximum Salary: $197000 

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.