Principal Quality Systems Engineer

Recruiter: Spencer Gregory Hale

Principal Quality Systems Engineer

Job Description:

We are seeking a Principal Quality Systems Engineer to manage the quality systems core within an integration project. This role involves partnering with cross-functional teams to achieve integration goals and overseeing the run-the-business aspects of quality systems.

Your key responsibilities will include:

• Influence key stakeholders through collaborative community engagement.  Help to connect the key SMEs across divisions and capitalize on networking skills to promote best practice sharing and efficient problem solving
• Support internal and external audits and audit responses to existing products.
• Manage quality systems core within an integration project.
• Monitor clinical product flow and device tracking.
• Oversee product approval for distribution.
• Support CAPA (Corrective and Preventive Actions) and nonconformance processes.
• Provide PMPC (Product Manufacturing Process Control) support.
• Maintain docket records and data control.
• Partner with cross-functional teams to achieve integration goals.

What We’re Looking for in You:

Minimum Qualifications

• Minimum of 7 years of experience in medical device quality systems.
• Bachelor's degree in science, health, or engineering 
• Understanding of design control and risk management.
• Understanding of US and International regulations including 21 CFR, 820, and ISO 13485 is required, as well as the Medical Device Directive, EUMDR, and EN ISO 14971.
• Familiarity with US and international regulations.
• Strong communication and presentation skills.
• Strong project management skills (preferred but not mandatory).
• Proficiency in Microsoft Office suite and Windchill.
• Ability to work with internal systems and external candidates.

Preferred Qualifications:

• Experience in managing quality systems within integration projects.
• Ability to work independently and as part of a team.
• Strong problem-solving skills and attention to detail.

Requisition ID: 604795 

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 www.bscbenefitsconnect.com--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.

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.

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.