Senior Engineer, Quality Engineering

Jobtailor; Milpitas (CA); On-site; USD 95,000 - 135,000; Full time

Job summary

Jobtailor is seeking a Quality professional to lead project teams, ensuring CTQ requirements are established and met, while improving process capability and managing product risks. The role involves leading design controls, coordinating risk management activities, and collaborating with engineering and product teams to address quality issues throughout development and change control.

The ideal candidate has a strong background in QSR/ISO medical device regulations, GDP/CAPA practices, and human

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 4 years of experience in Design/Process Engineering/Science/Statistics in a regulated industry.
• Experience with QSR/ISO medical device regulations, design controls, and risk management.
• Familiarity with GDP, CAPA, and document change control practices.

Responsibilities

• Provide quality leadership on product project teams and ensure CTQs cascading requirements are established and met.
• Manage risk and product harms, and improve process capability.
• Lead design control strategy development and implementation.
• Collaborate with partners to address quality issues during development, changes, and verification/validation.
• Lead risk management and human factors activities with engineers and development teams.
• Support Quality Management Systems, including Design Control, Risk Management, Change Control, Non-Conformance and Audits.

Skills

Communication

Attention to detail

Team collaboration

Presentation skills

Written and verbal communication

Quality risk management

Human Factors Engineering

Education

Bachelor's degree in Engineering

Job description

Responsibilities

• Quality leadership on product project teams and ensures the Critical to Quality (CTQs) attributes cascading requirements (for user needs to product, process, raw materials and test methods) are established, implemented and met.
• Ensures effective risk management or product harms and hazards and improves capability of processes.
• Leads development team in design control strategy and implementation.
• Collaborates with functional business partners to proactively address quality issues during new product development, design changes and product verification/validation.
• Leads activities associated with risk management and human factors. This includes working with engineers and product development to identify areas of high risk within their processes; establishing, monitoring and implementing risk mitigation plans; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
• Quality Management Systems support including Design Control, Risk Management, Change Control, Non-Conformance and Corrective Actions and Audits.

Requirements

• Bachelors or equivalent university degree in Engineering or other related technical field is required.
• 4 years working experience in Design/Process Engineering/Science/Statistics in a regulated industry.
• Strong communication, interpersonal and organizational skills.
• Practical understanding of QSR/ISO medical device regulations especially design controls, and risk management.
• Ability to function in a team environment and deliver on team objectives.
• Strong attention to detail.
• Strong written and verbal communication skills.
• Developed presentation skills.
• Preferred: Experience in Medical Device industry.
• Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
• Human Factors Engineering experience.