Sr Quality Systems Engineer - CAPA

Recruiter: Spencer Gregory Hale

Sr Quality Systems Engineer – CAPA

Role Overview:

The Sr. Quality Systems Engineer acts as the Quality representative to enhance communication and visibility of quality initiatives, supporting departmental, site, divisional and corporate goals. This role focuses specifically on supporting the CAPA program at Maple Grove, ensuring compliance with CAPA processes, medical device regulations, and company requirements. The position is hybrid, based in Maple Grove, MN, with 3 days per week in the office.

Key Responsibilities:

• Act as CAPA subject matter expert at Maple Grove, providing guidance and making sound decisions on how to best apply the processes efficiently, effectively and compliantly.
• Mentor CAPA teams (both cross-functional and direct team members) with applying tools in root cause analysis, problem-solving methodologies, corrective action plans, effectiveness verifications and project management activities.
• Skilled at identifying, prioritizing, communicating and resolving systematic quality issues
• Providing continuous and rigorous assessment of CAPA records to ensure they are robust, compliant with BSC processes and regulations (FDA, ISO 13485 and Medical Device Requirements), and timely throughout the CAPA lifecycle.
• Determining and tracking actionable CAPA metrics and trends to assess program effectiveness and influence key stakeholders’ engagement
• Support site and global CAPA initiatives and continuous improvement projects.

Required Qualifications:

• Bachelor’s degree with 5+ years, or Master’s degree with 3+ years, in medical device manufacturing, quality, or regulatory/compliance.
• Understanding of quality system requirements as stated in 21 CFR Part 820 and ISO 13485.
• Strong technical writing, documentation, and analytical skills.
• Attention to detail and risk-based decision-making.

Preferred Qualifications:

• Degree in Science or Engineering.
• 5+ years in Quality Systems and/or CAPA management.
• Training/certification in ISO 13485 and FDA QSR (21 CFR Part 820).
• Proficiency in Power BI and Tableau.
• Proactive able to work independently, as a team leader or member, and enjoy being part of a highly visible team.
• Project management experience
• A passion for continuous improvement.

Requisition ID: 619373 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

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 identity, 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.