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Job Description

Insight Global is seeking a Quality Engineer to join our pharmaceutical client in Boston. The role will support the design and development of Class II medical devices. This role partners closely with Product Development, Regulatory, Manufacturing, and Quality Control to ensure compliance and product excellence.

Key Responsibilities:

-Provide quality assurance for device design, including design controls, risk management, and Design History File (DHF) documentation.

-Review and approve design documents (e.g., test plans, protocols, risk analyses, engineering drawings).

-Conduct DHF audits and support remediation efforts.

-Lead and document risk assessments (dFMEA, uFMEA, pFMEA) in compliance with FDA, EU, and global standards.

-Evaluate product designs for quality, manufacturability, and regulatory compliance.

-Support change control processes and ensure timely updates to DHF.

-Contribute to new product commercialization and continuous improvement.

-Investigate product complaints and quality issues using root cause analysis.

-Support vendor management, audits, and documentation for product release.

Compensation:

$60.00/hr to $65.00/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: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

-Education & Experience: M.S. in Engineering with 3+ years, or B.S. with 5+ years of relevant experience.

-Industry Background: 2–5 years in a regulated medical device environment; experience with device-biologic combination products preferred.

-Product Development: Proven track record in medical device development, including authorship of Design History Files, risk management leadership, and lifecycle management.

-Technical Expertise: Strong knowledge of process instrumentation, test method development, and component/system validation.

-Regulatory Knowledge: Deep understanding of cGxP, ISO 13485, ISO 14971, and 21 CFR 820.

-Analytical Skills: Solid grasp of statistical methods; excellent technical writing and presentation abilities.

-Work Style: Able to work independently, manage multiple projects, and meet deadlines with minimal supervision.

-Team Collaboration: Strong interpersonal skills and a collaborative mindset.