Senior Quality Analyst Job Details

Job Description

Senior Quality Analyst

Work mode: Hybrid

Onsite Location(s): Ottawa, ON, CA

Additional Locations: Canada-ON-Ottawa

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, well give you the opportunity to harness all thats 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, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.

About the role

Boston Scientific is hiring a Senior Quality Analyst for a 1-year contract role that is critical to the success of our radiopharmaceutical launch in China. This position will support the project manager in establishing the foundation for radiopharmaceutical operations, ensuring quality systems are effectively implemented and aligned with regulatory requirements.

This is a unique opportunity to contribute to a high-impact initiative and help shape Boston Scientifics entry into the radiopharmaceutical space in one of the worlds most dynamic healthcare markets.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local Ottawa 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:

• Collaborate closely with the Quality Systems Project Manager to ensure timely and effective delivery of the radiopharmaceutical Quality Management System that meets internal and external requirements.
• Collaboration with cross-functional teams including Regulatory Affairs, R&D, Design Assurance, Supplier Engineering and all key project stakeholders
• Interpret and apply global regulatory requirements, with a strong focus on Chinese market standards and expectations
• Author and review quality documentation including SOPs and work instructions
• Author and review internal supplier quality documentation
• Review and approve external supplier quality documentation including validation protocols, and technical reports
• Collaborate on training curriculum design and support cross-functional teams through training and mentorship
• Support external regulatory inspections and ensure timeline closure of audit findings and CAPAs
• Other activities as required

Required qualifications:

• Bachelors or advanced degree in Engineering, Life Sciences, Pharmacy, or related field.
• Extensive experience with medical device and pharmaceutical quality management systems
• Demonstrated history of effective teamwork across multicultural and cross-functional groups.
• Detail-oriented with a proactive approach to problem-solving
• Resilient, patient, and action-oriented; adept at navigating ambiguity and adapting to evolving priorities.
• Fluency in English required; Mandarin proficiency is an asset.
• Ability to travel domestically and/or internationally up to 10 PERCENT

Preferred qualifications:

• Proficiency in Mandarin
• Experience with Chinese regulatory standards or international launches
• Ability to quickly establish business relationships with colleagues and external partners

Requisition ID: 615723

Minimum Salary: $79,700

Maximum Salary: $158,200

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 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 salaried, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).

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) isnt just business, its personal. And if youre 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

Job Segment: Compliance, Pharmaceutical, Regulatory Affairs, Quality Manager, Quality, Legal, Science

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