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Job Description

This position ensures product lifecycle activities—spanning design, development, production, distribution, and service—comply with applicable procedures, standards, and regulations. Acting as a technical leader and mentor, the role provides project or program-level guidance, applies quality tools and risk management principles, and promotes continuous improvement across cross-functional teams. The position also supports audits, leads quality initiatives, and may supervise other Quality Engineers.

Key Responsibilities:

Lead and review quality documentation throughout the product lifecycle.

Advise teams on compliance with regulations, standards, and procedures—including those related to cybersecurity and privacy.

Ensure product quality and complete documentation before approvals.

Drive implementation of design controls and product realization requirements.

Lead or support new product development, design changes, and investigations.

Apply statistical and quality tools to evaluate results, risk analyses, and validations.

Guide corrective/preventive actions (CAPAs) and support audit readiness.

Approve change orders related to product performance, processes, and labeling.

Mentor Quality Engineers and contribute to training and knowledge sharing.

Lead cross-functional projects and quality system improvements.

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

- Bachelor’s degree (or equivalent) in engineering or science.

- Minimum 9 years of experience in medical devices, pharmaceuticals, diagnostics, or clinical laboratories; or 8 years with an advanced degree.

- Strong foundation in engineering/science principles across R&D, quality control, manufacturing, and design.

- Proven ability to apply technical and engineering problem-solving skills to complex issues.

- Deep knowledge of domestic and international regulatory and quality standards.

- Proficient in quality management methods and statistical techniques (e.g., Lean, Six Sigma).

- Understanding of risk-based approaches to compliance, data analysis, and decision-making.

- Having experience - being a true document owner of risk management documentation

- PFMEAs - owning and changing/updating Risk documentation - ASQ Certified Quality Engineer (CQE).

- Lean or Six Sigma certification. null

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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].