Quality Analyst Ii, Post Market Surveillance

4 months ago

Mississauga, Canada Boston Scientific Corporation Full time

**Quality Analyst II, Post Market Surveillance**:

- Remote Eligible: Hybrid- Onsite Location(s): Mississauga, ON, CA**Additional Locations**: Canada-ON-Mississauga; Canada-ON-Toronto

**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**

We are a growing team looking for a Quality Analyst II to join our Product Performance group within the Design Assurance Quality team. The Quality Analyst II continues to integrate with the broader Access Solutions community, receives ongoing training in the various phases of engineering and the Quality Management System, and conducts tasks of increased scope and complexity. They are responsible for collaboration with stakeholders within the company on post-market surveillance/post-market clinical follow-up planning, analysis, and reporting, including preparing data and analyses for cross-functional teams, risk management activities, and participation in quality deliverables.

**Your responsibilities will include**:

- Perform trending, studies & statistical analyses of post-market surveillance information to determine actions to improve product performance & reduce complaints.
- Conduct work to support complaint investigations, risk management activities, and other post-market surveillance activities.
- Author post-market surveillance reports and present review findings to cross functional groups.
- Some autonomy may be exercised to make decisions within an area of expertise, where supported by precedents or clearly defined procedures. Methodologies and results are typically reviewed in detail.
- Adhere to all requirements of the Quality Management System.
- Demonstrate company values, work with integrity, and be a supportive team member.
- Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.
- Other duties as required.

**Required qualifications**:

- Bachelors degree in Engineering or relevant Science
- 2+ years of relevant experience, preferably in the field of Post-Market Surveillance, Post-Market Clinical Follow-Up and/or Clinical Evaluation
- Understanding of design controls, risk management, and statistical analysis techniques
- Proficiency in MS Office and experience using Excel for data analysis
- Excellent analytical and communication skills (written and oral)
- Organization and time management skills

**Preferred qualifications**:

- Thesis-based Master’s or PhD degree
- Specific medical device experience in Cardiology
- Experience in writing Post-Market Surveillance reports and/or Periodic Safety Update Reports
- Detailed understanding of EU MDR regulations for Post-Market Surveillance
- Statistical sampling plan experience for Post-Market Clinical Follow-Up studies
- Experience with statistical/analytics software, Power BI or SAS tools preferred

**What we have to offer**:

- Hybrid working model for many roles combining on-site and remote work, paired with flexible working hours.
- Comprehensive total rewards package, including bonus, RRSP or 401k employer matching, tuition reimbursement, health & dental benefits, and a health or lifestyle (your choice) spending account.
- Generous paid time off, including vacation days, personal days, statutory holidays, and a Holiday shutdown
- A strong commitment to mental health and well-being, including a company-paid meditation app, meditation rooms in some buildings, fully trained Mental Health First Aid staff members, and weekly yoga/HIIT/Pilates/mindfulness online professionally-led classes for all employees.
- Headquarters based roles offer functional outdoor spaces (bring your laptop to one of multiple wi-fi connected outdoor patios to work) and access to a beautiful ravine trail system for lunchtime walks
- Employer subsidized gourmet, high-quality, healthy meals available onsite, freshly delivered multiple times a week.
- Strong senior leadership commitment to Inclusion and Diversity; many opportunities to join I&D committees and spearhead I&D initiatives; employer-hosted roundtables with external experts, guest speakers and workshops/celebrations.
- Formal mentorship program, robust biweekly internal networking events and multiple communication streams open to senior management for all employees to provide continuous feedback
- Employee-friendly work environment, with opportunity to participate in employee-led clubs (for example, book club, French club, gardening club, rock climbing club, boardgame club, tea club), and support to create new clubs
- Employee recognition rewards platform (Guusto) - rec

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