Boston Scientific Principal Quality Systems Engineer 

United States, Minnesota 

977016347

Spencer Gregory Hale

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.

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.