Job Description

Additional Location(s): N/A

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 Quality Auditor II performs detailed audits of practices at company manufacturing plants and sites to ensure that policies and procedures comply with FDA, ISO, MDD and other relevant standards and regulations. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies. Consults with management to establish practices and procedures that comply with FDA regulations and applicable standards.

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:

• Responsible for conducting and confirming follow-up actions on Corporate/Divisional/Site Compliance Audits.
• Responsible for working with management and/or teams on validations, protocol and process reviews, and implementation of requirements in compliance programs.
• Plan and conduct scheduled audits to assess compliance with FDA, ISO, MDD, and other external requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Participate in planning, coordination, and implementation of corporate and site audit policies. To include review of updated GMP/QSR regulations and current FDA and non-US requirements (ISO) and incorporation into internal programs where appropriate.
• Review, understand, and implement changes related to ISO/GMP changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs.
• Participation with Corporate and divisional QA on policy/procedure/ guideline development. Includes generation, review, and implementation of these documents.

Required Qualifications:

• Minimum of a Bachelors Degree
• Minimum of 2 years previous experience auditing to medical device Quality System regulations
• Previous experience developing audit plans and audit reports
• Ability to evaluate compliance to applicable external and internal regulations and requirements

Preferred Qualifications

• Education/Certification: Lead Auditor ISO 13485 Certification
• Education/Certification: ASQ Certified Quality Auditor (CQA) or Certified Medical Device Auditor (CMDA)
• Experience: Demonstrated lead auditor experience
• Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management, including but not limited to: 21 CFR Part 820, ISO 13485, EU MDR 2017/745, AIMDD, MDD, MHLW Ordinance 169, MDR SOR/98-282, 21 CFR Part 211, ISO 14971, Therapeutic Goods Regulations 2002, Resolution RDC 16/2013, 21 CFR Part 4, as applicable to site
• Ability to lead others to achieve common goals and objectives, e.g., on specific internal audits
• Ability to demonstrate equanimity, effectiveness, and leadership in challenging situations
• Strong verbal / written communication, interpersonal and organizational skills
• Ability to communicate effectively with all levels of the organization
• Must be proactive and able to work independently with minimal supervision
• Ability to work effectively in a hybrid mode: work from home, work from site

Requisition ID: 610371  

Minimum Salary: $ 69500  

Maximum Salary: $ 132000  

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.

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.

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