Job Description

Additional Locations: Canada-ON-Ottawa
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
The Senior Quality Manager will have a passion for leadership to develop and lead a high-performance team in pursuit of our burning ambition, to serve more patients with improved product experiences. Reporting to the Director of Quality, the Senior Quality Manager will lead a team of Quality Specialists in Supplier oversight of contract manufacturing operations to ensure that product meets a high standard of customer satisfaction and conforms to global standards and regulatory requirements. They will drive continuous improvement in product quality and compliance through the development and maintenance of quality policies; driving discipline and clarity in corrective actions; monitoring and responding to field performance and customer feedback and partnering with multiple stakeholders including regulatory, clinical, development, post market, quality systems and program management to coordinate and influence project teams. They will represent the Quality function at all levels.
Your responsibilities will include:

• Drive proactive quality within own business unit and be a champion at a site level.
• Build relationships with supplier site(s) and business unit(s) to enable a culture of open communication channels.
• Own and drive deliverables related to Product Performance, Quality and Compliance, key partner in all department goals and objectives.
• Apply sound, systematic problem-solving methodologies to identify, communicate and resolve quality issues.
• Implement a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Talent Acquisition and HRBP support.
• Develop direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Contribute to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Provide vision and plans for future improvements; translate Best4 goals into department goals into individual objectives and key measurable results.
• Identify, develop and implement processes to improve department performance.
• Ensure sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining capability.
• Monitor and evaluate projects and quality department progress to support business with new products/indications and process development based on coordination with management and project leaders.
• Represent function through direct interaction with external auditors.
• Actively participate in divisional complaint review board forum, Franchise Leadership Team, Complaint Review Board, Quality Management Review, Functional Alignment Meetings and Communities of Practice.
• Other duties as required.

Required qualifications:

• Bachelor's degree in Engineering, Life Sciences, Science, or related field of study
• 7+ years of relevant work experience
• 5+ years of direct supervisory experience with a passion for team development
• Medical Device or regulated industry experience
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality system requirements associated with product development, design controls, and product risk management
• Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EU MDR, EN ISO 13485, EN ISO 14971
• Strong verbal and written communication skills, both technical and conversational
• Decision making and negotiation skills, individually and within groups
• Experience in managing multiple projects across multiple organizational disciplines
• Travel up to 10% - domestic and international required

Preferred qualifications:

• Experience in active implantable radioactive medical device handling

Requisition ID: 614265
Minimum Salary: $109900
Maximum Salary: $218300
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) 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!

Skills Required