Quality Assurance Engineer III

Quality Assurance Engineer III

Work mode: Remote in Country

Location: Marlborough, MA, US, 01752

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.

Quality Assurance Engineer III

This role has the flexibility to be remote or hybrid.

About the role:
The Quality Assurance Engineer III will play a critical role in the design history file remediation and integration of a Boston Scientific acquisition. He/she/they will be responsible for working with a cross-functional team to analyze historical product documentation and create a Boston Scientific-compliant product file for future submission and maintenance. He/she/they will build the risk management file and work with R&D, marketing, sales organizations, and other departments, as well as external customers to ensure the integration and remediation are adequate. He/she/they will ensure that information, post-market feedback, and historical documentation are fed back to the R&D and marketing organizations as part of the risk management and design input systems.

Key Responsibilities will include:

• Analyzes customer complaints, events, and other post-marketing surveillance data to build Boston Scientific (BSC) compliant risk management documentation and monitoring methodology.
• Reviews, creates, and approves DHF documentation, including design inputs, design outputs, risk assessments, verification and validation protocols, and design change documentation.
• Leads any quality-related integration activities, ensuring all necessary documents are created, organized, and representative of the product’s current state.
• Identifies gaps or inconsistencies and implements corrective and preventive actions as needed.
• Works closely with Regulatory Affairs to support regulatory submissions.
• Provides guidance to cross-functional teams on DHF requirements, risk management and best practices.
• Assists in continuous improvement efforts related to DHF management and quality system processes.
• Communicates project status and arising challenges through formal presentations to management committees and design teams, supporting cross-functional requests.

Required Qualifications:

• Minimum of a Bachelor’s degree
• Minimum of 5 years of related experience in Quality
• Available for 10-20% international travel

Preferred Qualifications:

• Experience on CFR 820.30 and Risk Management, CAPAs and Usability Files
• Experience with statistical tools (Ex. Mini tab)
• ISO 14971:2019, CFR 820, EU MDR 2017/745, MDD 93/42/EEC
• Must work effectively in a dynamic work environment
• Strong problem solver with excellent verbal and written communication skills
• Technical background with a passion for continuous improvement

Requisition ID: 569628

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
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 prohibited substance 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.