Principal Quality Systems Engineer & Records Controls Process Steward, Global Quality Systems

Boston Scientific

  • Marlborough, MA
  • $103,700 per year
  • Permanent
  • Full-time
  • 15 days ago
Additional Location(s): US-MN-Maple Grove; US-CA-Valencia; US-MN-Arden HillsDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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: Boston Scientific is seeking Principal Quality Systems Engineer & Records Control Quality Steward for its Global Quality Systems group. The purpose of this role is to provide strong leadership & stewardship of the Records Controls process & Community of Practice, as well as ownership of the digital systems transformation in the Document Management space.The Principal Quality Systems Engineer will work as part of a broad global team within the Global Quality system and particularly with the team across the Document & Records Control process to identify synergies to progress Boston’s Scientific’s goals & objectives, including supporting Acquisition Integration strategies. They will also mentor other Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate.Purpose StatementThe Principal Quality Systems Engineer will primarily lead the Corporate Quality System team in technical expertise as the sub-process Steward for Records Control within a Global Quality System. They will support the development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of processes and systems conform to establish standards and agency guidelines. They will also champion all compliance activities within assigned area.The Principal Quality Systems Engineer will create a culture of compliance and facilitate adherence to the BSC Quality System and all appropriate regulations that BSC follows. They will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.Your responsibilities will include:
  • Quality System Stewardship for assigned area.
  • Lead the development and ownership of the strategic roadmap, including digital transformation strategy.
  • Lead identified activities through leadership of the Community of Practice.
  • Implement training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
  • Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
  • Lead or oversee quality projects of major magnitude and scope. Provide input and oversight to overall quality project portfolio and project priorities.
  • Support external audits through leadership as an audit-facing SME, back rooms, training for SMEs, creation of storyboard material and site level support for Global procedures.
  • Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal.
  • Act as a CAPA owner for corrective actions necessary to improve the global processes.
  • Champion departmental or cross-functional quality initiatives.
  • Provide project direction, coaching, and mentoring for other team members, as required.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.
Required qualifications:
  • Minimum of Bachelor’s degree in relevant field
  • Minimum of 5 years of Quality Systems experience
  • Regulated industry experience
  • Understanding of regulations and standards applicable to the BSC Global Quality System and Document & Records Control processes (ISO 13485, 21 CFR 820, EU MDR, etc.).
Preferred qualifications:
  • Advanced degree
  • Medical device experience
  • Document and/or Records Management
  • Digital product ownership and/or IT project experience
  • Strong analytical and communication skills
  • Demonstrated inclusive leadership skills
  • High degree of integrity, professionalism, and the ability to establish credibility internally and externally
  • High sense of urgency and commitment to execution
Requisition ID: 608517Minimum Salary: $ 103700Maximum Salary: $ 197000The 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 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.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!At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. 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.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. 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. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. 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.Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. 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.

Boston Scientific