MQSA Engineer

Job Description

Our client is seeking an MQSA Engineer to join the Quality Systems team. This role ensures compliance with microbiological quality and sterility assurance standards across manufacturing and product development processes. The ideal candidate will have expertise in sterility assurance, microbiology, and regulatory compliance within a medical device environment.

Key Responsibilities

-Develop, implement, and maintain sterility assurance programs for medical devices in compliance with FDA QSR, ISO 13485, and ISO 11135/11137 standards.

-Provide technical leadership for cleanroom validation, bioburden testing, and environmental monitoring programs.

-Support sterilization process development and validation (e.g., ethylene oxide, gamma, steam, or gaseous sterilization methods).

-Conduct risk assessments related to microbiological contamination and sterility assurance.

-Collaborate with R&D, Manufacturing, and Quality teams to ensure sterility requirements are integrated into product design and production processes.

-Author and maintain SOPs, protocols, and reports for sterility assurance activities.

-Lead investigations for sterility-related non-conformances and implement corrective/preventive actions (CAPA).

-Support internal and external audits, including regulatory inspections.

-Provide training and guidance on microbiological quality and sterility assurance best practices.

Compensation:

$40/hr to $50/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Employees in this role will enjoy a comprehensive benefits package starting on day one of

employment, including options for medical, dental, and vision insurance. Eligibility to enroll in

the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this

role will have access to paid sick leave and other paid time off benefits as required under the

applicable law of the worksite location.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

Education: Bachelor's degree in Microbiology, Biomedical Engineering, Life Sciences, or related field (Master's preferred).

Experience:

-3+ years in sterility assurance or microbiological quality within medical device, pharmaceutical, or biotech industries.

-Knowledge of sterilization standards and validation requirements.

Technical Skills:

-Familiarity with ISO 11135, ISO 11137, and ISO 11737 standards.

-Experience with cleanroom operations and contamination control.

-Strong analytical, problem-solving, and documentation skills.