CAPA & Quality Systems Engineer II - Investigations Lead

Boston Scientific; Maple Grove (MN); Híbrido; USD 72.000 - 136.000; Tempo integral

Benefícios oferecidos por esta vaga

Hybrid work model

Resumo da vaga

Boston Scientific in Maple Grove seeks a Quality Systems Engineer II to support the CAPA process, including nonconformances, within a hybrid work model (in-office at least three days/week). Relocation/sponsorship are not provided for this role.

You will mentor cross-functional CAPA teams, lead investigations, ensure compliance with FDA regulations and ISO 13485, and drive corrective actions and continuous improvement across the site.

Qualificações

• Bachelor's degree in a relevant field.
• Minimum of 2 years' experience in the medical device or pharmaceutical industry.
• Understanding of CAPA regulatory requirements and best practices.
• Familiarity with 21 CFR 820 and ISO 13485.
• Experience leading cross-functional initiatives or projects.
• Strong problem-solving and root cause analysis skills.
• Excellent communication and stakeholder management; able to make risk-based decisions.

Responsabilidades

• Mentor CAPA teams on root cause analysis and corrective actions.
• Coordinate activities to meet CAPA timelines using project management practices.
• Prepare robust, compliant CAPA records in the CAPA system.
• Guide investigations for nonconformances including containment and risk assessment.
• Ensure CAPA activities comply with FDA, ISO 13485, and global processes.
• Apply structured problem-solving to identify and resolve systemic quality issues.
• Collaborate with cross-functional stakeholders to standardize best practices.
• Track CAPA metrics and support site, regional, and global CAPA initiatives.
• Drive continuous improvement and preventive quality culture.

Conhecimentos

CAPA process

Root cause analysis

Project management

Cross-functional collaboration

Documentation

Formação

Bachelor's degree

Ferramentas

CAPA database system

Descrição da vaga

Boston Scientific in Maple Grove seeks a Quality Systems Engineer II to support the CAPA process, including nonconformances, within a hybrid work model (in-office at least three days/week). Relocation/sponsorship are not provided for this role.

You will mentor cross-functional CAPA teams, lead investigations, ensure compliance with FDA regulations and ISO 13485, and drive corrective actions and continuous improvement across the site.