Quality Engineer

One of Insight Global's biotech clients is seeking a detail-oriented and proactive Quality Engineer - CAPA to lead quality initiatives across the product lifecycle. This role is ideal for someone with a strong foundation in quality systems, risk management, and continuous improvement, particularly in regulated environments.

Key Responsibilities:
- Creates and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
- Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
- Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
- Ensures success of quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability.
- Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.
- Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
- Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
- Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary.
- Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.
- Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.
- Applies continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle.
- Builds effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestones

Compensation:
$40-48/hour
Exact compensation may vary based on several factors, including location, 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 HR@insightglobal.com.To 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/.

- Minimum required Education: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
- Minimum required Experience: Minimum 2 years of experience with Bachelor's in areas such as Quality Engineering, Safety Engineering, R&D Engineering or equivalent OR no prior experience required with Master's Degree
- Experience with process validation using statistical tools and transitioning new products to production.
- Familiarity with design control processes including input validation, verification, and design transfer.
- Strong documentation skills for quality plans across hardware, software, and systems.
- Ability to lead CAPA activities, root cause analysis, and implement corrective actions.
- Knowledge of risk management, regulatory compliance, and audit readiness.
- Skilled in integrating post-market surveillance insights into product lifecycle improvements.

- Six Sigma Green Belt Preferred Skills: Design Quality Management Data Analysis & Interpretation Design for Quality (DFQ) Root Cause Analysis (RCA) CAPA Methodologies Regulatory Requirements Privacy, Safety and Security Risk Assessment Technical Documentation Continuous Improvement Product Quality and Reliability Defect Management Design Verification Planning Design Validation Planning Product Test Design

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.