About the Role:
The Senior Quality Engineer plays a critical role in ensuring that products and processes meet the highest standards of quality and reliability. This position is responsible for leading quality assurance initiatives, developing and implementing quality control systems, and driving continuous improvement across manufacturing and development teams. The Senior Quality Engineer collaborates closely with cross-functional teams including design, production, and supply chain to identify potential quality issues and implement effective corrective actions. This role requires a strategic thinker who can analyze complex data, lead root cause investigations, and influence quality culture throughout the organization. Ultimately, the Senior Quality Engineer ensures that customer expectations are consistently met or exceeded, contributing to the company’s reputation for excellence and compliance with industry standards and regulations.
Minimum Qualifications:
- Bachelor’s degree in Biomedical Engineering, Quality Management, or a related technical field.
- 5+ years of experience in quality engineering or quality assurance roles within a manufacturing or product development environment.
- Strong knowledge of quality management systems (QMS) and industry standards such as ISO 9001, 21CFRPart 210 and 211.
- Proficiency in root cause analysis tools and methodologies such as 8D, Fishbone diagrams, and FMEA.
- Experience with statistical process control (SPC) and data analysis software.
Preferred Qualifications:
- Certification as ASQ CQE/CQA/CSSBB or equivalent.
- Experience working in regulated industries such as pharmaceuticals, medical devices, or aerospace.
- Familiarity with regulatory requirements including FDA 21CFR, ISO 13485, or AS9100 standards.
- Advanced degree in Engineering, Quality, or related discipline.
- Proficiency with quality management software and ERP systems.
Responsibilities:
- Program ownership of continued process verification (CPV)
- Lead and coach teams on complex investigations; ensure statistical/technical rigor and business continuity.
- Facilitate site PFMEA reviews; institutionalize risk registers; align mitigation control strategies.
- Quality by Design (QbD): Partner with Manufacturing, Science, and Technology (MSAT) for control strategy updates and CPV enhancements; enable Product Process Qualification (PPQ) readiness where applicable.
- Lead continuous improvement projects impacting yield, RFT, and cycle time.
- Co-lead audit front-room topics; lead back-room coordination and commitments tracking.
- Analyze quality data and metrics to identify trends, risks, and opportunities for continuous improvement.
- Train and mentor junior quality engineers and other team members on quality best practices and methodologies.
Skills:
The Senior Quality Engineer utilizes analytical skills daily to interpret complex data sets and identify quality trends that impact product performance. Strong problem-solving abilities are essential for conducting root cause analyses and developing effective corrective actions that enhance product reliability. Communication skills are critical for collaborating with cross-functional teams, presenting findings, and training colleagues on quality standards. Leadership skills enable the engineer to guide quality initiatives and mentor junior staff, fostering a culture of continuous improvement. Additionally, proficiency with quality tools and software supports efficient documentation, audit preparation, and compliance management, ensuring that quality objectives align with organizational goals.
