Quality Assurance Engineer

About the role

The Quality Assurance Engineer (QAE) supports the New Product Development (NPD) team, working cross-functionally to support various Quality activities including design controls, V&V planning, QA test development, and application/execution of the QMS. This role specializes in QA vs. QC, requiring familiarity with the Medical Device Product Development process.

Responsibilities

• Hands-on test development and qualification, along with participation in design reviews, design verification, and validation testing.
• Evaluation and processing of design change qualifications, assisting with the development of product specifications.
• Risk evaluation and assessment, including data collection and statistical analysis as well as review of Engineering protocols and reports.
• Composition and submission of protocols and reports if applicable, as well as other QMS or other Quality-related responsibilities as assigned.
• Support Product Development Life Cycle from concept through production.
• Participate in risk management activities including review failure mode effects analysis (FMEA).
• Collaborate with the team to drive Quality improvement projects and corrective and preventative actions (CAPA).

Requirements

• 2-3+ years' professional experience in QA or similar with medical device industry experience, ideally in new product development (NPD).
• Prior background with and knowledge of Quality Management Systems (QMS).
• Bachelor's degree in Biomedical Engineering or related field.
• Former experience with and ability to apply statistical analysis tools.
• Familiarity with and ideally some level of experience with firmware and/or software validation.

Qualifications

• Preferred: Robotics or systems engineering experience within the medical device industry.
• Quality Engineer Certification.
• Lever Six Sigma Training and/or Certification.
• Knowledge of ISO 14971 and ISO 13485 regulatory requirements.
• Minitab or other statistical program experience.
• Problem-solving techniques and root cause analysis, 5 Why, etc.
• Design Tolerance Analysis and methods.
• Familiarity with Solid Works / CAD.

Skills

• Strong attention to detail.
• Capable of both collaborating effectively and working independently.

Benefits

Not specified.

Pay

$90,000 - $120,000 / year

Schedule

Not specified.