Quality Specialist II

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:

Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities with primary focus on complaint handling. Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.

Collaborates with Quality management to recommend, design and implement functional process improvements.Develops, establishes and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements.May own and develop metrics and support measuring performance to quality objectives. May provide compliance guidance and support for technical development concepts, regulatory, operational, or systems/services.

Your responsibilities include:

• Support the development/enhancement of product data quality systems.
• Support data management activities.
• Support compliance analysis and metrics.
• Participates in projects supporting Best 4 Quality
• Leads and/or participates on NCEP/CAPA teams.
• VIP project management
• Procedure management and ownership
• Develops and delivers communication and training.
• Other duties as necessary or required by the department or organization.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required Qualifications:

• Bachelor's degree and 1-3 years of work experience
• Complaint handling experience
• Ability to read, analyze and report data.
• Excellent written and oral communication
• Strong sense of responsibility and attention to detail
• Ability to actively engage divisional and regional resources.
• Ability to work with a virtual team.
• Microsoft Office Suite skills (Excel, Word, PowerPoint, SharePoint)
• Experience with Microsoft Dynamics 365, Help Desk Ticket System, Azure DevOps
• Experience as an NCEP/CAPA owner.
• Understanding of quality management systems
• Understanding of data management / information management
• Project management experience
• Technical writing and editing skills.

Preferred Qualifications:

• 2-3 Years of experience
• Previous Quality Assurance or complaint handling experiences preferred.
• Team player with excellent coordination, interpersonal and communication skills.
• Self-directed requiring minimal supervision.
• Understanding of the Boston Scientific Cardiac Diagnostics quality system
  
  

Requisition ID:595991

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal 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 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's status, age, mental or physical disability, genetic information or any other protected class.

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.