QA Engineering Lead - Medical Devices & Compliance

Mizuhosi; Union City (CA); Hybride; USD 172 000 - 198 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Comprehensive benefits package

Résumé du poste

Mizuho OSI is seeking a Senior Manager, Quality Assurance Engineer to lead the QA Engineering group and ensure compliance with regulatory requirements. This role reports to the Senior Director of Quality Assurance and Regulatory Affairs and oversees budgeting, staffing, and cross-functional collaborations for new product launches.

The position emphasizes leadership, strategic planning, and enforcing quality systems across ISO and QSR standards, to support company-wide compliance and continuous

Qualifications

• Bachelor’s degree in Engineering, Sciences or Business; MS preferred.
• Ten years of Quality experience with at least five years in a management capacity.
• 3–5 years of experience working with sterile medical devices.
• Knowledge of ISO and QSR requirements in the medical device industry.
• Experience with FDA regulations and ISO standards (21 CFR Part 820, 11, 806; ISO 13485; EU MDR).
• Strong leadership, planning and communication skills.

Responsabilités

• Mentor, train and provide technical support to the Quality Assurance Engineering Group.
• Provide feedback and performance reviews.
• Administer and enforce company policies; manage performance and career development.
• Provide guidance and leadership to the QA Engineering group; manage resources.
• Coordinate and support internal audit program and compliance activities.
• Participate in internal quality auditing system and external regulatory audits/inspections.
• Develop and implement quality system procedures (ISO and QSR).
• Assist design projects for new product introduction ensuring compliance.
• Maintain quality system; generate trend reports for audits.
• Implement process improvements across the organization.

Connaissances

Leadership

Quality assurance

Regulatory compliance

Cross-functional collaboration

Training and development

Formation

MS preferred

Bachelor’s degree in Engineering, Sciences or Business

Outils

Microsoft Office 365

Description du poste

Mizuho OSI is seeking a Senior Manager, Quality Assurance Engineer to lead the QA Engineering group and ensure compliance with regulatory requirements. This role reports to the Senior Director of Quality Assurance and Regulatory Affairs and oversees budgeting, staffing, and cross-functional collaborations for new product launches.

The position emphasizes leadership, strategic planning, and enforcing quality systems across ISO and QSR standards, to support company-wide compliance and continuous