Quality Assurance Manager - MedTech Startup

HealthCare Recruiters International; San Francisco (CA); On-site; USD 130,000 - 160,000; Full time

Job summary

A Bay Area MedTech startup is looking for a Quality Assurance Manager to lead their Quality department and ensure compliance with regulatory standards. The role involves managing the quality management system and collaborating with various stakeholders. This position offers a competitive salary and opportunities for professional growth.

Benefits

Medical insurance

Vision insurance

Qualifications

• Experience with Quality Systems for medical device products.

Responsibilities

• Lead and manage the Quality department staff and activities.
• Prepare and maintain the quality management system (QMS).
• Collaborate with stakeholders to establish QMS procedures.
• Lead external regulatory audits.

Skills

Quality Systems

Job description

Quality Assurance Manager - MedTech Startup

HealthCare Recruiters International provides the pay range for this position:

Base pay range: $130,000.00/yr - $160,000.00/yr

Your actual pay will depend on your skills and experience. Please talk with your recruiter to learn more.

Opportunity Overview

We are seeking a Quality Assurance Manager for a Bay Area MedTech startup. The company has two commercialized products generating revenue.

Responsibilities:

• Lead and manage the Quality department staff and activities.
• Prepare and maintain the quality management system (QMS), SOPs, and Quality Manual to ensure compliance with ISO 13485, FDA QSR 21 CFR Part 820, and other regulatory requirements.
• Collaborate with cross-functional stakeholders to establish procedures that meet QMS standards.
• Lead external regulatory audits.

Must Have Experience:

- Experience with Quality Systems for medical device products.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing

Referrals can increase your chances of interviewing at HealthCare Recruiters International by 2x.

Inferred Benefits:

• Medical insurance
• Vision insurance

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