The Senior Quality Design & Development Engineer will be responsible for overseeing various quality functions, particularly focusing on Design Control (product development), Regulatory Compliance, and supporting manufacturing processes. This role also involves conducting qualitative and quantitative data analysis, complaint investigation, training, metrology, and gage R&R, while contributing to strategic quality system initiatives. Collaboration across departments and ensuring adherence to industry standards, such as FDA and ISO13485, is critical to this position.
Key Responsibilities:
Product & Process Qualification:
Lead the development and execution of operational and process qualifications for customer manufacturing processes in collaboration with engineering teams.
Risk & Hazard Analysis:
Assist and initiate the development or update of Failure Modes and Effects Analysis (FMEA) and Hazard Analysis as required by project needs.
Quality Planning:
Create and manage Quality Plans for development projects, establishing clear inspection and acceptance criteria for incoming, in-process, and final product inspections.
Design Control Documentation:
Oversee and review Design Control activities, ensuring alignment with project requirements for Phase Reviews and Product Verification testing.
Vendor Audits & Qualifications:
Conduct vendor audits and manage qualifications to maintain compliance with quality standards and regulatory guidelines.
Internal Audits & Compliance:
Manage the internal audit schedule, lead audits, train internal auditors, and assess compliance with FDA, ISO13485, and internal Quality System requirements. Investigate findings and report on observations.
Problem-Solving & Quality Metrics:
Apply systematic problem-solving techniques to resolve quality issues, including Corrective and Preventive Actions (CAPA), Customer Complaint Records (CCR), and Nonconformance Material Reports (NMR). Conduct trending analysis on quality metrics.
Clean Room Oversight:
Ensure ISO Class 7 clean room compliance by reviewing and analyzing testing and monitoring reports, and providing quality oversight.
Cross-Functional Collaboration:
Represent quality engineering in phase reviews and across all stages of product development, working closely with R&D, Manufacturing, and QA teams to ensure quality objectives are met.
Audits & Continuous Improvement:
Serve as a key member of the customer and third-party audit team, potentially leading audit efforts. Ensure a culture of continuous improvement across all quality processes.
Additional Duties:
Comply with company, quality, and safety standards, and support other quality functions as assigned. This position is not remote and requires consistent, punctual attendance.
Qualifications:
Education & Experience:
Technical Skills:
Tools & Methodologies:
Soft Skills:
Preferred Certification:
Other Requirements: