Job Description
As our Senior Quality Engineer, you'll be the cornerstone of quality assurance for designated product lines, owning everything from product design manufacturability to supplier partnerships and customer satisfaction. You'll interpret and apply Quality Systems while developing the Standard Operating Procedures that keep our organization compliant and competitive.
Responsibilities:
- Strategic Quality Leadership: You'll develop and maintain Design History Files while serving as the go-to expert for quality standards and protocols across the organization
- Problem-Solving at Scale: Apply sophisticated statistical tools to analyze data, identify root causes, and implement corrective actions for complex quality challenges
- Audit Authority: Take the lead on both internal and external audits, potentially serving as Lead Auditor and ensuring our processes exceed industry standards
- Data-Driven Decision Making: Monitor and trend quality indicators, assess Critical To Quality (CTQ) parameters, and conduct risk assessments that shape predictable product design and flow
- Cross-Functional Collaboration: Partner with project teams and operations to integrate new products seamlessly into manufacturing while sharing quality insights and solutions
- Regulatory Excellence: Maintain FDA and ISO regulatory compliance with laser focus on product design for manufacturability, customer complaints, assembly/test procedures, inspection protocols, and validation throughout development
- Quality Intelligence: Generate and communicate Critical to Quality indices, providing actionable recommendations to project teams and operations as issues emerge
- Metrics Mastery: Drive improvement in key quality metrics including First Pass Acceptance rates, Quality Notifications, and Complaint data
- Process Innovation: Develop departmental programs focused on continuous improvement and standardization across DS Diagnostic Systems
- New Product Integration: Support the coordinated launch of new products into Manufacturing and Operations environments
- Compliance Guardian: Ensure all DS Diagnostic Systems divisional and departmental policies, procedures, practices, and facilities meet applicable regulatory requirements
- Documentation Leadership: Develop and maintain Design/Device History Files in full accordance with FDA requirements
- CAPA Ownership: Initiate Corrective and Preventive Actions (CAPAs) and lead investigation and corrective action processes
- Supplier Quality Management: Monitor quality indicators for purchased materials and ensure consistent supplier qualification practices
Required Qualifications:
- BS in related field required with minimum of 3 years of Quality Operations or Regulatory experience in the medical device environment or 5 years in manufacturing environment
- MS with 3 years of experience.
- Typical degree in Electrical or Mechanical or Industrial Engineering.
- Experience and understanding of electro-mechanical instrumented systems.
- Experience handling multiple projects simultaneously in a fast-paced environment.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Preferred Qualifications:
- Pharma/Medical device industry experience
- Experience with Minitab or other statistical analysis platforms
- Professional certifications such as Certified Quality Auditor/Certified Quality Engineer, Six Sigma
