Principal Quality Systems Engineer

Additional Location(s):US-MN-Maple Grove; Costa Rica-Coyol; Costa Rica-Heredia; Ireland-Clonmel; Ireland-Cork; Ireland-Galway; US-IN-Spencer

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:

The Principal Quality Systems Engineer supports the development and maintenance of Global quality assurance policies procedures processes and controls ensuring that performance and quality of processes and systems conform to established standards and agency guidelines. Acts globally as a subject matter expert on BSC production and process control quality requirements policy and procedures. Serves as a global quality representative to improve awareness visibility and communication on quality initiatives to support global quality goals and priorities. Collaborates with global quality management to recommend design and implement procedural improvements. May mentor and train less experienced staff as well as other cross-functional stakeholders in implementing quality processes and procedures as appropriate.

This role is hybrid and can be based out of any BSC production site- Arden Hills Maple Grove Spencer Galway Cork Clonmel Coyol or Heredia.

Key Responsibilities:

• Support the sub-process stewards in development and maintenance of process metrics and/or methods as required for performance continous improvement and monitoring for the Process Acceptance and Control processes.
• Support continuous improvement through the Quality System Steward and Community of Practice model against strategic roadmap plans of activities.
• Implement training technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Review and assess changes to standards and regulations applicabe the Production and Process Control processes for potential impact to BSC and initiate projects as needed to ensure continued compliance.
• Support or oversee quality projects of major magnitude and scope. Provide input and oversight to overall quality project portfolio and project priorities.
• Support external audit front rooms and 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 as appliable within the global processes

Required Qualifications:

• Minimum of a Bachelors degree
• Minimum of 7 years experience in relevant field(s) related to medical device quality systems and/or production and process control or equivalent.
• Understanding of regulations and standards applicable to the BSC Global Quality System and Process Validation and Production Control (ISOCFR 820 EU MDR etc.).

Preferred Qualifications:

• Understanding of specific regulations and standards applicable to BSC Global Quality System and Process Validation and Production Control (ISO 14971 ISOCFR 210/211 etc.).
• Experience with enterprise control systems (e.g. Siemens Manufacturing Execution System Product Data Management-Windchill etc.)
• Excellent interpersonal skills including strong presentation skills
• Demonstrated inclusive leadership skills
• Strong analytical skills

Requisition ID:620912

Minimum Salary:$99100

Maximum Salary: $188300

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see 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) 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!

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 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. 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 Companys policies or protocols change with regard to COVID-19 vaccination.

Among other requirements Boston Scientific maintains specificprohibited substancetest 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.