Quality Engineer II (QE II)

Digitailor; California; On-site; USD 90,000 - 130,000; Full time

Job summary

Digitailor is seeking a Quality Engineer II to ensure the quality, safety, and regulatory compliance of medical devices across the product lifecycle. You will guide CAPA, risk management, supplier quality, and investigations while partnering with R&D, Regulatory, Operations, and Manufacturing.

The role involves design control participation, design verification/validation support, and leading quality activities on moderate-complexity projects.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline or equivalent.
• 3–5 years of quality engineering in a regulated industry, preferably medical devices.
• Experience with FDA regulations, ISO standards, and QMS.

Responsibilities

• Maintain and improve the Quality Management System (QMS) to comply with FDA 21 CFR Part 820 and ISO 13485.
• Lead supplier quality, CAPA, investigations, and change control activities.
• Support V&V, design controls, and risk management across product lifecycle.
• Mentor junior quality staff and collaborate with cross-functional teams.

Skills

Quality engineering

Root cause analysis

CAPA

Lean Six Sigma

Project management

Data analysis

Communication skills

Cross-functional collaboration

Risk management

Problem solving

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related field

Job description

Job Overview The Quality Engineer II (QE II) plays a critical role in ensuring the quality, safety, and regulatory compliance of medical devices throughout the product lifecycle. This position leads quality engineering activities related to product development, manufacturing support, supplier quality, investigations, corrective and preventive actions (CAPA), and risk management. The QE II partners closely with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, Operations, and Supplier Quality, to drive compliance, continuous improvement, and product excellence. This role operates independently on moderate-complexity projects, serves as a key quality representative within cross-functional teams, and provides guidance and mentorship to junior quality personnel.

Key Responsibilities

Quality Systems & Compliance Support and maintain the Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory requirements. Author, review, and approve quality system documents including SOPs, work instructions, quality records, and related documentation. Participate in internal audits, supplier audits, and regulatory inspections, including supporting audit readiness and corrective action activities. Ensure quality system processes are effectively executed and continuously improved to maintain compliance and operational excellence. Product Development & Design Quality Lead quality engineering support for moderate-scale product development projects. Participate in design control activities, including design reviews, risk assessments, design transfer, and change management. Support design verification and validation activities to ensure products meet design requirements, intended use, and applicable regulatory standards. Collaborate with engineering teams throughout the product lifecycle to ensure quality and compliance requirements are met. Investigations, CAPA & Risk Management Lead nonconformance investigations and CAPA activities, including root cause analysis, corrective action implementation, and effectiveness verification. Utilize structured problem-solving methodologies such as 5 Whys, Fishbone Analysis, FMEA, and statistical tools to drive resolution of quality issues. Support product and process risk management activities in accordance with ISO 14971 and company procedures. Facilitate change control activities and risk assessments associated with product, process, and system changes. Manufacturing & Supplier Quality Provide day-to-day quality engineering support to manufacturing and operations. Review and approve Device History Records (DHRs), batch records, inspection results, and quality documentation. Lead Material Review Board (MRB) activities, including assessment and disposition of nonconforming materials. Support validation activities, including IQ/OQ/PQ for manufacturing processes, equipment, and software systems. Lead supplier quality activities, including qualification, audits, performance monitoring, corrective actions, and supplier development initiatives. Review supplier quality documentation, certifications, and quality agreements. Continuous Improvement & Leadership Analyze quality and manufacturing data to identify trends, risks, and improvement opportunities. Lead or support continuous improvement initiatives utilizing Lean, Six Sigma, or other quality improvement methodologies. Track, monitor, and report quality metrics and key performance indicators (KPIs). Serve as a quality representative on cross-functional project teams. Provide mentorship and guidance to Quality Engineer I team members and quality inspectors as needed.

Minimum Qualifications

Education Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent combination of education and experience. Experience 3-5 years of quality engineering experience in a regulated industry, preferably within the medical device industry. Experience working with FDA regulations, ISO standards, and Quality Management Systems. Experience leading investigations, CAPA activities, nonconformance management, and root cause analysis. Experience supporting manufacturing quality and product development activities.

Preferred Qualifications

Experience in medical device manufacturing and quality systems. Certified Quality Engineer (CQE) or other ASQ certification. Experience supporting regulatory audits and inspections. Working knowledge of Lean Manufacturing and Six Sigma methodologies. Experience with supplier quality management and process validation activities. Familiarity with APQP, PPAP, and advanced quality planning methodologies.

Specific Knowledge & Skills

Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable medical device regulations and standards. Experience with design controls, risk management, verification and validation, change control, complaint handling, and CAPA processes. Knowledge of process validation methodologies, including IQ/OQ/PQ. Understanding of quality engineering tools and methodologies, including FMEA, root cause analysis, statistical analysis, and data trending. Experience interpreting and analyzing quality and manufacturing data to drive decision-making and process improvements. Strong project management and organizational skills with the ability to manage multiple priorities. Excellent verbal and written communication skills, including the ability to communicate technical information effectively to diverse audiences. Ability to influence and collaborate effectively across cross-functional teams without direct authority. Strong attention to detail and commitment to quality, compliance, and continuous improvement.

General Skills & Competencies

Demonstrates sound judgment and analytical problem-solving skills. Effectively manages competing priorities and deadlines. Builds productive relationships across departments and organizational levels. Communicates professionally and effectively in both written and verbal formats. Demonstrates initiative, accountability, and ownership of assigned responsibilities. Contributes to a culture of teamwork, compliance, and continuous improvement. Maintains a high level of integrity, professionalism, and customer focus.

Travel & Physical Requirements

Travel up to 20% may be required. Primarily office and manufacturing environment. No special physical requirements beyond those necessary to perform the essential functions of the position. TriMed, Inc.