Senior Quality System Manager

Boston Scientific • Quincy, MA

1d • $131,700 - $250,200

About The Position

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. 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! 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. 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 identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. 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. 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. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Requirements

• Bachelor's degree in engineering, life sciences or a related discipline.
• Minimum of 7 years' experience in quality systems, quality assurance or regulatory compliance within a regulated industry.
• Minimum of 3 years' experience leading or managing professional teams.
• Comprehensive knowledge of GMP, Quality System Regulation (QSR), ISO and Health Canada requirements.
• Demonstrated experience managing audits, CAPA systems and regulatory inspections.
• Strong leadership, problem-solving and cross-functional collaboration skills.
• Experience supporting distribution or supply chain operations.
• Experience leading Drug Wholesale licensure compliance activities.
• Advanced degree in a related field.

Responsibilities

• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and documented quality processes.
• Ensure appropriate resources, including personnel and tools, are available to maintain Quality System compliance.
• Establish and promote a work environment that supports the Quality Policy and Quality System.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level