Job Description

Roth Staffing is looking for a Senior Quality Assurance Engineer for our client in Tempe, AZ. This is an exciting opportunity to work for a global leader in life-saving medical devices with a strong corporate culture and competitive pay.

Job Description:

Our client is hiring a Senior Engineer, Advanced Quality for our Sustainability Solutions team supporting our reprocessing product line. You will be a key member of the new product development team ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast-paced environment with opportunities to win for yourself, the company, and patients around the world. This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer.

Workplace Flexibility: Candidate must reside within a commutable distance to Tempe, AZ

Key Responsibilities :

• Represents Quality Assurance on New Product Development (NPD) cross-functional teams, collaborating with R&D, Regulatory Affairs, Advanced Operations, and Marketing to meet product development metrics.
• Leads Risk Management activities, including creating and implementing Risk Management Files, identifying hazards, and ensuring compliance with corporate and divisional design control procedures.
• Plans, designs, and implements inspection, testing, and evaluation methods to ensure product and production reliability, applying advanced statistical techniques for test sample size determinations.
• Leads Design Reviews to ensure design and process robustness, compliance with applicable regulations (e.g., QSR, ISO 13485), and proper risk analysis for new medical devices.
• Plans, performs, and reviews engineering risk analyses, test methods, and process improvements to enhance product quality and manufacturing efficiency.
• Provides leadership in product development by guiding engineering principles, interpreting test data, and developing process and product protocols.
• Mentors junior staff, leads departmental initiatives, and influences multiple teams to drive quality and regulatory compliance throughout the development process.
• May interact with customers to address product quality concerns, provide training on quality assurance and GMP topics, and support continuous improvement initiatives.

Required Experience & Education:

• Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering.
• Minimum of 2+ years' experience in an engineering role.
• Experience in data collection, data analysis, and scientific method.

Preferred:

• Experience with Quality Concepts such as Risk Management, CAPA, Audits, Statistics.
• Previous medical device industry experience preferred
• Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.
• Six Sigma Green Belt or ASQ CQE.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

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