Senior Quality Manager

Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Your responsibilities will include: Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. Builds strategic partnerships to further departmental and organizational objectives. Develops and executes Post Market Compliance programs, policies, and processes by utilizing technical/professional knowledge and skills. Manages department headcount budget to ensure effective resource planning, including recruitment, interviewing, selection, training, coaching, development, coordination of assignments and workload priorities, goal setting, termination, and performance management. Develops, monitors and appropriately adjusts the annual budget for department(s) including determining appropriate staff levels, schedules and resources Provide oversight to work done offsite and by 3rd party vendors. Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement. Develop and facilitate training and training support for the Post Market Surveillance organization. Apply sound, systematic problem-solving methodologies cross-functionally when identifying, prioritizing, communicating, and resolving quality issues. Bachelor's degree in in a related field including Engineering, Life Sciences, Medical/Clinical or the equivalent combination of education and work experience Minimum of 5 years of related quality management experience Minimum of 2 years direct or indirect leadership experience Substantial working knowledge of CFR 820, 803, 806, ISO 13485 and ISO 14971 Demonstrated experience building effective organizations and leveraging teams to accomplish objectives Strong technical writing skills and effective communication skills Advanced knowledge of quality principles including risk management practices Requisition ID: 606455 Minimum Salary: $ 122100 Maximum Salary: $ 232000 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 non-exempt (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 exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. 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 identify, 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.