Overview
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.
Base pay range
$140,000.00/yr - $185,000.00/yr
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.
REQUIRED SKILLS AND EXPERIENCE
- 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
NICE TO HAVE SKILLS AND EXPERIENCE
- ASQ Certified Quality Engineer (CQE).
- Lean or Six Sigma certification.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Quality Assurance
- Medical Equipment Manufacturing