What are the responsibilities and job description for the Senior Quality Engineer position at Talently?
Job Title: Senior Quality Engineer
Location: On Site - Boulder, Colorado, United States
Salary: $95,000-$125,000
Skills: ISO, FDA
About the Medical Devices Industry / The Opportunity:
Join a leading organization in the medical devices sector dedicated to improving patient lives through innovative, high‑quality products. Our client operates a fast‑growing manufacturing environment that emphasizes regulatory compliance, continuous improvement, and cross‑functional collaboration. The Senior Quality Engineer role offers the chance to shape quality systems, lead investigations, and drive excellence across Class II and Class III device production.
Responsibilities:
- Lead and conduct quality investigations, root cause analyses, and CAPA activities to resolve product and process issues.
- Develop, implement, and maintain quality systems and procedures ensuring ISO 13485 and FDA 21 CFR Part 820 compliance.
- Participate in cross‑functional teams to embed quality into product development, design control, and manufacturing processes.
- Lead design control and change control efforts, including updates to design history files and change documentation.
- Collaborate with operations on lean initiatives to enhance manufacturing efficiency and product quality.
- Create and deliver operator training programs and qualification assessments.
- Conduct internal audits and interface with FDA and ISO auditors during inspections.
- Monitor supplier performance, develop quality metrics, and drive continuous improvement projects.
Must-Have Skills:
- Strong knowledge of ISO 13485:2016 and FDA 21 CFR Part 820 regulations.
- Extensive experience with quality investigations, root cause analysis, and CAPA management.
- Proficiency in design control and change control processes for medical devices.
- Expertise in risk management, statistical analysis, and process validation.
- Hands‑on experience with supplier quality management and internal auditing.
- Ability to apply Lean Manufacturing principles to improve quality and efficiency.
- Excellent communication, problem‑solving, and mentorship skills.
Nice-to-Have Skills:
- Familiarity with Six Sigma methodologies and tools.
- Experience with statistical software (e.g., Minitab) for data analysis.
- Knowledge of medical device software validation requirements.
- Proficiency in MS Office suite, especially Excel for data reporting.
- Exposure to product lifecycle management (PLM) systems.
Salary : $95,000 - $125,000