Senior (Lead) Quality Systems Engineer

Agile Search Inc.; Billerica (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Agile Search is seeking a Senior Quality Systems Engineer for a commercial-stage medical device company, based on-site in Billerica, MA. You will own the QMS end-to-end, including ISO 13485, FDA QMSR, risk management, supplier qualification, post-market surveillance, and MDR reporting, helping scale the organization for global distribution.

5+ years of deep medical device quality system experience and proficiency in 21 CFR 820, ISO 13485, and ISO 14971 are required; IEC 62304/60601-1, 510(k) or

Qualifications

• 5+ years of deep experience with medical device quality systems.
• Proficiency in 21 CFR 820, ISO 13485, and ISO 14971.
• Experience with MDR reporting and regulatory submissions is a plus.
• IEC 62304 and 60601-1 expertise.
• 510(k) or CE technical file experience.
• CQE, CMDA, or lead auditor certification is a plus.

Responsibilities

• Own QMS end-to-end, perform gap analysis for growth and lead implementations.
• Lead meetings, risk management and provide recommendations to drive quality improvements.
• Oversee internal audits and CAPA through root cause investigations.
• Develop quality metrics and apply statistical methods to inform risk-based decisions.
• Own supplier qualification and audits, including post-market surveillance.
• Ensure MDR reporting and maintain continuous improvement of the quality culture.

Skills

QMS ownership

Risk management

Internal audits

CAPA

Statistical methods

Supplier qualification

Regulatory compliance

Quality metrics

Voice of quality

Tools

Quality management software

QMS tools

Job description

Opportunity to build a company's quality management system for the next stage of growth, including added product capability, building for scale and global distribution.

About Agile Search's client:

A growth-stage medical technology company recently engaged with a strategic partner and positioned for global expansion.

Agile Search is conducting interviews for a Senior Quality Systems Engineer to join a commercial stage company and help them build out their Quality Management System for their next chapter.

Role specifics:

Assume ownership of the QMS end to end, ISO 13485 and FDA QMSR; perform gap analysis for the company's growth, contribute directly to building the system, leading meetings as required, conducting risk management, making recommendations, voice of quality leading implementations.

Lead internal audits and CAPA through to root cause, build the quality metrics and statistical methods that drive risk-based decisions.

Own supplier qualification and audits, post-market surveillance and MDR reporting.

Contribute to directly shaping the quality culture for this expanding, multidisciplinary team.

Full time, on-site hire located in Billerica, MA.

5+ years of deep experience with medical device quality systems, ideally with some of that experience with a growing small company or building or evolving a QMS.

Proficiency in the application of 21 CFR 820, ISO 13485, and ISO 14971.

Comfortable with statistical methods, sampling plans, and validation data.

Energized by a fast-paced, growth stage company environment.

Big plusses for this role:

• Prior startup or early-stage medical device growth experience
• Proficiency in electromechanical medtech
• Proficiency with Software Quality Systems
• Expertise applying IEC 62304 and 60601-1
• 510(k) or CE technical file experience
• CQE, CMDA, or lead auditor certification