Senior Manager, RDQA

📋 Description

• Provides quality system methodology guidance, support and review for medical device products
• Actively participates in cross-functional design teams assessing design documentation for quality
• Works with product development engineering and manufacturing engineering to translate design
• Serves as a technical resource for problem investigations to guide root cause analysis / corrective
• Facilitates and leads design and reliability activities related to Design, Manufacturability, and
• Ensure that product development projects and changes to existing products are conducted in

🎯 Requirements

• 10+ years’ experience working in the Medical Device industry, 2+ years in project management
• Minimum of a BS in Engineering or Scientific discipline; MS preferred
• Strong knowledge of Medical Device development activities
• Proven expertise with interpreting, applying, and leading others in compliance with 21 CFR Part 820
• Skilled in requirements analysis, including testable and measurable specifications
• Familiar with reliability analysis and test methods and test method validation

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Long-term incentive programs