Senior Quality Engineer

Job Title: Senior Quality Engineer

Location: Roseville
Salary: $75,000 to $80,000

Position Summary:

We are seeking a results-driven and detail-oriented Senior Quality Engineer to join our growing Quality team. The ideal candidate will serve as a key quality representative across cross-functional teams and projects, driving quality excellence through product development, manufacturing, and continuous improvement efforts. This role plays a critical function in ensuring compliance with FDA regulations, ISO 13485, and company quality standards while supporting new product development and sustaining engineering initiatives.

Key Responsibilities:

• Lead quality engineering support for product development and manufacturing processes in alignment with regulatory requirements and internal quality systems.
• Ensure product and process compliance with applicable FDA QSR, ISO 13485, and other international regulatory standards.
• Participate in design reviews, risk assessments (e.g., FMEA), and the establishment of product and process specifications.
• Develop and execute protocols for verification and validation (V&V) of products, equipment, and processes.
• Drive the CAPA process, perform root cause analyses, and implement effective corrective and preventive actions.
• Support internal and external audit activities; assist in preparing responses and implementing corrective actions as needed.
• Analyze trends in quality data and metrics to identify opportunities for continuous improvement.
• Collaborate with Engineering, Manufacturing, Regulatory Affairs, and suppliers to resolve quality issues and enhance product reliability.
• Author and maintain Quality documentation, including SOPs, technical reports, inspection plans, and validation records.
• Provide mentoring and leadership to junior engineers and cross-functional project teams.

Required Qualifications:

• Bachelor’s degree in Engineering or a related technical field.
• Minimum of 5 years of quality engineering experience, preferably in the medical device or other regulated manufacturing environment.
• Solid understanding of FDA Design Controls, ISO 13485, 21 CFR Part 820, and risk management per ISO 14971.
• Demonstrated experience with design and process validation, including protocol development and execution (IQ/OQ/PQ).
• Experience with statistical analysis, root cause analysis (e.g., 5 Whys, Fishbone), and quality tools (e.g., control plans, SPC).
• Proficient in quality system software, Microsoft Office Suite, and common engineering tools.

Preferred Qualifications:

• Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt.
• Experience with supplier quality management and external manufacturing partners.
• Knowledge of Minitab or other statistical software.
• Strong interpersonal skills and the ability to work collaboratively across departments and leadership levels.

Why Join Us?

• Work on meaningful innovations that improve patient outcomes.
• Be part of a collaborative, quality-focused culture.
• Grow professionally in a supportive and regulated environment committed to excellence.

Apply now to bring your quality expertise to the forefront of medical innovation.