Medical Murray
Base pay range: $60,000.00/yr - $80,000.00/yr
Associate R&D Quality Assurance Engineer The
Associate R&D Quality Assurance Engineer
works within the Quality Department to support development project deliverables and contribute to R&D efforts from concept through production for disposable medical devices—including catheters, catheter-based delivery systems, and other disposable devices used across disciplines such as cardiology, neurology, and urology.
This position partners closely with cross-functional teams to ensure that new product designs, processes, and documentation meet the company’s objectives for quality, regulatory compliance, and customer satisfaction.
Duties and Responsibilities
Follow and enforce the Quality Management System, including applicable SOPs.
Represent Quality on development teams to ensure compliance with internal and external quality and regulatory standards.
Partner with R&D to establish and implement design controls based on risk management, customer requirements, and manufacturability.
Develop and maintain Design History Files and Quality Plans for development projects.
Contribute to risk management activities in accordance with ISO 14971.
Review and provide input on design and manufacturing documentation—including specifications, drawings, and procedures—to ensure manufacturability and compliance.
Develop and optimize inspection documentation, including inspection procedures, forms, and sampling plans.
Perform inspections on manufactured products and support verification and validation testing activities.
Assist with creation and execution of test protocols and documentation of results (design verification, validation, lot release, test method validation, etc.).
Train technicians and inspectors as needed.
Review and approve lot history records and quality documentation for accuracy and compliance.
Participate in investigations, nonconformance reports, and corrective/preventive actions (CAPA).
Support customer complaint investigations and returned product evaluations.
Participate in supplier qualification and monitoring activities, including defining incoming inspection criteria.
Assist in internal and external audits of the quality system.
Apply systematic problem-solving and root cause analysis methods to resolve quality issues.
Support the Quality Department as needed to achieve departmental and company goals.
Maintain direct billing above 70%.
Demonstrate understanding of design and development processes by leading and executing full project deliverables to meet customer expectations.
Qualifications
Education: Bachelor’s or Master’s degree in Engineering or a related technical field, or equivalent experience.
Experience: 0–2 years of experience in Quality or R&D Engineering within the medical device industry.
Familiarity with ISO and FDA Quality Systems preferred.
Experience with design controls and Design History File development desired.
Certifications: Green Belt Certification preferred.
Skills, Knowledge, and Abilities
Understanding of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 cGMP standards.
Proficient in medical device testing, protocol development, and report writing.
Knowledge of statistics and data analysis tools (e.g., SPC).
Strong computer skills, including Microsoft Office Suite.
Excellent analytical, organizational, and problem-solving abilities.
Effective verbal and written communication skills.
Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
Why Join Us Join a team dedicated to advancing innovative medical device solutions that improve patient outcomes. You’ll collaborate with experts across multiple disciplines, contribute to cutting‑edge product development, and be part of a company that values quality, teamwork, and continuous improvement.
Medical Murray is an equal opportunity employer.
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Associate R&D Quality Assurance Engineer The
Associate R&D Quality Assurance Engineer
works within the Quality Department to support development project deliverables and contribute to R&D efforts from concept through production for disposable medical devices—including catheters, catheter-based delivery systems, and other disposable devices used across disciplines such as cardiology, neurology, and urology.
This position partners closely with cross-functional teams to ensure that new product designs, processes, and documentation meet the company’s objectives for quality, regulatory compliance, and customer satisfaction.
Duties and Responsibilities
Follow and enforce the Quality Management System, including applicable SOPs.
Represent Quality on development teams to ensure compliance with internal and external quality and regulatory standards.
Partner with R&D to establish and implement design controls based on risk management, customer requirements, and manufacturability.
Develop and maintain Design History Files and Quality Plans for development projects.
Contribute to risk management activities in accordance with ISO 14971.
Review and provide input on design and manufacturing documentation—including specifications, drawings, and procedures—to ensure manufacturability and compliance.
Develop and optimize inspection documentation, including inspection procedures, forms, and sampling plans.
Perform inspections on manufactured products and support verification and validation testing activities.
Assist with creation and execution of test protocols and documentation of results (design verification, validation, lot release, test method validation, etc.).
Train technicians and inspectors as needed.
Review and approve lot history records and quality documentation for accuracy and compliance.
Participate in investigations, nonconformance reports, and corrective/preventive actions (CAPA).
Support customer complaint investigations and returned product evaluations.
Participate in supplier qualification and monitoring activities, including defining incoming inspection criteria.
Assist in internal and external audits of the quality system.
Apply systematic problem-solving and root cause analysis methods to resolve quality issues.
Support the Quality Department as needed to achieve departmental and company goals.
Maintain direct billing above 70%.
Demonstrate understanding of design and development processes by leading and executing full project deliverables to meet customer expectations.
Qualifications
Education: Bachelor’s or Master’s degree in Engineering or a related technical field, or equivalent experience.
Experience: 0–2 years of experience in Quality or R&D Engineering within the medical device industry.
Familiarity with ISO and FDA Quality Systems preferred.
Experience with design controls and Design History File development desired.
Certifications: Green Belt Certification preferred.
Skills, Knowledge, and Abilities
Understanding of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 cGMP standards.
Proficient in medical device testing, protocol development, and report writing.
Knowledge of statistics and data analysis tools (e.g., SPC).
Strong computer skills, including Microsoft Office Suite.
Excellent analytical, organizational, and problem-solving abilities.
Effective verbal and written communication skills.
Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
Why Join Us Join a team dedicated to advancing innovative medical device solutions that improve patient outcomes. You’ll collaborate with experts across multiple disciplines, contribute to cutting‑edge product development, and be part of a company that values quality, teamwork, and continuous improvement.
Medical Murray is an equal opportunity employer.
#J-18808-Ljbffr