Top 3 technical skills that you are required for the role:
Risk Management
Medical Device
Collaborative and Quality Minded
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid, on-site 3 days per week average
Job Title: Senior Systems Quality Engineer
Job Description:
This company, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Senior Systems Quality Engineer to join our innovative team. The ideal candidate will have a strong background in New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. This role will be pivotal in ensuring the development and maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards and customer expectations.
Key Responsibilities:
Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards.
Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle.
Conduct risk assessments and manage risk mitigation activities in accordance with ISO 14971 and other applicable standards.
Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections.
Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements.
Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports.
Design Validation and Verification Responsibilities:
Define and manage systems requirements to ensure clarity, completeness, and testability. Collaborate with the system engineering team to define, refine, and manage system level requirements to ensure alignment with customer needs, clarity, completeness and testability.
Oversee the requirements management process to ensure traceability and compliance. Responsible for verifying all design requirements are present and appropriately incorporated int risk management documentation.
Develop and maintain critical to quality (CTQ) matrices to identify key product characteristics and ensure they meet customer needs and regulatory requirements ensuring traceability between them.
Lead project teams in the testing of Clinician requirements of devices and products. Including development of protocols, reports and execution of the Design Validations.
Risk Management Responsibilities:
Develop and manage risk management plans and reports, and conduct regular risk reviews.
Collaborate with the system engineering team to define thorough hazard analysis to identify potential risks and mitigate them effectively.
Conduct Failure Modes and Effects Analysis (FMEAs) to systematically evaluate potential failure modes and their impacts in collaboration with project teams.
Analyze and review product complaints to predict and prevent future issues.
Collaborate with the system engineering team to define detailed risk analysis to ensure all potential risks are identified and mitigated.
Ensure product security measures are implemented and maintained to protect against potential vulnerabilities.
Develop and manage post-market surveillance plans to monitor product performance and safety in the field.
Maintain and curate risk logs to ensure accurate and up-to-date risk documentation.
Qualifications:
Minimum Requirements:
Education: Bachelor's degree in Engineering, or a related technical field. Advanced degree preferred.
Experience: Minimum of 8 years of applicable experience
Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.
Preferred Qualifications:
Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred.
Experience: Experience in Quality Assurance, Engineering
Industry Experience: Medical device industry.
Technical Skills: Proficient in systems engineering methodologies, quality assurance practices, risk management, and regulatory compliance.