Quality Assurance Analyst II
3 hours ago
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. The Quality Assurance Analyst II will work in a fast‑paced environment to analyze customer complaints for the EP Complaint Management Center (CMC) to determine which are regulatory reportable and will coordinate activities with internal, field, and end‑use customers. The focus of this role will be products within the EP portfolio. The QA Analyst II will be responsible for adhering to proper complaint‑handling procedures per the Code of Federal Regulation (CFR) and other governmental regulations. The QA Analyst II will communicate event investigation results via regulatory reports and other written communication, as appropriate and applicable. 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 Review complaint communications and assess complaints for regulatory reportability, and potential impacts to patient safety and business operations. Apply clinical knowledge, as related to product usage, to evaluate complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, laboratory analysis results, and other relevant sources. Establish regulatory reportability decisions using event investigation and regulatory decision models. Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government‑mandated regulations. Write Medical Device Reports (MDRs), Vigilance, and other regulatory reports, ensuring timely submission to the appropriate regulatory authorities. Accurately and consistently apply codes to events. Review coding and investigations with engineering, laboratory, and other internal staff, as appropriate. Effectively compose written communication, detailing the clinical observations, investigations and/or product analyses and corrective actions, as applicable, to physicians and other end‑use customers. Required Qualifications Bachelor’s degree or equivalent education 1+ years of experience in medical device complaint processing & reporting Excellent written and verbal communication skills Preferred Qualifications Self‑motivated, goal‑driven and results‑oriented team player Critical thinking and good time management skills University Degree or equivalent with a focus in Biology, Health Sciences, Biotechnology or Engineering 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 #J-18808-Ljbffr
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Quality Assurance Analyst II
3 hours ago
Mississauga, Canada Boston Scientific Full timeOverviewAdditional Locations: Canada-ON-Mississauga; Canada-ON-TorontoDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...
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Quality Assurance Analyst II
3 hours ago
Mississauga, Canada Boston Scientific Full timeAbout the role: The Quality Assurance Analyst II will work in a fast-paced environment to analyze customer complaints for the EP Complaint Management Center (CMC) to determine which are regulatory reportable and will coordinate activities with internal, field, and end use customers. The focus of this role will be products within the EP portfolio. and the QA...
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Quality Assurance Analyst II
3 hours ago
Mississauga, Canada Boston Scientific Full timeAdditional Locations: Canada-ON-Mississauga; Canada-ON-TorontoDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...
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Quality Assurance Analyst
3 hours ago
Mississauga, Canada Axelon Services Corporation Full timeJob Title: Quality Assurance Analyst Work Mode: Hybrid Location: Mississauga, ON Pay: Competitive Overview: Global Financial Firm located in Mississauga, ON has an immediate contract opportunity for an experienced Quality Assurance Analyst. This role is currently on a Hybrid Schedule, requiring reliable internet, computer, and Android or iPhone for remote...
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Quality Assurance Analyst
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Quality Assurance Analyst
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Mississauga, Canada Novo Nordisk Full time**Quality Assurance Analyst **(12 Months Contract) **PURPOSE OF THE JOB** - The Quality Assurance Analyst is responsible for: - Performing Quality audits and activities - Ensuring products are released to Market Authorization - Managing non-conformity and change control process **Key Areas of Responsibilities** **Product Release: (50% of time spent)** -...
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Quality Assurance Analyst
2 weeks ago
Mississauga, Canada goeasy Full time**Quality Assurance Analyst** If you are looking to join one of Canada’s fastest growing companies, goeasy Ltd. is the place for you! Recognized as **Canada’s Most Admired Corporate Cultures**, **GTA's Top 100 Employers,** one of **Canada’s Top 50 Fintech’s** and **North America’s Most Engaged Workplaces,** we want the best and brightest to join...
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Mississauga, Canada Boston Scientific Gruppe Full timeA leading medical technology company is seeking a Quality Engineer II to join their Design Assurance Quality team in Mississauga. You will work closely with product teams to ensure compliance with design controls, manage risk files, and review verification protocols. Ideal candidates will have a Bachelor's degree in Biomedical, Mechanical, or Electrical...
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Mississauga, Canada Boston Scientific Gruppe Full timeA leading medical technology company is seeking a Quality Engineer II to join their Design Assurance Quality team in Mississauga. You will work closely with product teams to ensure compliance with design controls, manage risk files, and review verification protocols. Ideal candidates will have a Bachelor's degree in Biomedical, Mechanical, or Electrical...
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Mississauga, Canada Boston Scientific Gruppe Full timeA leading medical technology company is seeking a Quality Engineer II to join their Design Assurance Quality team in Mississauga. You will work closely with product teams to ensure compliance with design controls, manage risk files, and review verification protocols. Ideal candidates will have a Bachelor's degree in Biomedical, Mechanical, or Electrical...
