Job Description:
We are seeking a Quality Engineer to partner with our Engineering and Advanced Operations teams to drive the development of new medical devices. This role will focus on defining design requirements, developing manufacturing processes, and leading risk management activities to ensure the highest level of product and process quality.
Key Responsibilities:
* Develop Quality Assurance Documentation: Create and maintain quality assurance documentation to support new product development processes and regulatory submissions.
* Lead Quality System Maintenance: Identify and correct deficiencies in procedures and practices to ensure compliance with regulatory requirements.
* Partner with Cross-Functional Teams: Collaborate with project teams to lead product and/or process design and development activities.
* Risk Management: Lead risk management activities for new product development projects, evaluating overall residual risk and presenting final risk/benefit justifications to executive leadership.
* Design Reviews: Present risks associated with product use during Design Reviews and track design, documentation, and manufacturing process mitigations throughout the development process.
* Manufacturing Process Development: Partner with Advanced Operations to develop manufacturing processes for new products, ensuring efficient and effective production methods.
* Statistical Analysis: Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, and resolve quality problems.
* Inspection Plans: Develop, review, and approve inspection plans, routers, and product drawings for new products.
* Product Design Transfers: Support product design transfers to internal and/or external manufacturing facilities.
* Team Leadership: Provide support and direction for other Quality Engineers and contribute to the completion of final design verification and validation reports.
* Predicate Product Analysis: Evaluate predicate products for relevant quality issues that may impact new product development projects.
* Critical Quality Attributes: Analyze and define critical quality attributes for product and process through risk analysis techniques.
Requirements:
1. Education: BS in a science, engineering, or related discipline; MS, CQE, or CRE preferred.
2. Work Experience: Minimum of 5 years experience; Six Sigma Green or Black belt preferred.
3. Knowledge and Competencies:
* Medical Device Industry: Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
* Advanced Quality Tools: Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
* CAD Drawing Interpretation: Demonstrated ability to read and interpret CAD drawings.
* Regulatory Knowledge: Thorough knowledge and understanding of US and International Medical Device Regulations and strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
* Project Management: Must possess strong project management skills, able to manage multiple tasks simultaneously, and effectively work cross-functionally with other departments.