Quality Engineer II

for Medical Devices. The Sustaining Quality Engineer t akes the lead with quality initiatives with inter-organizational impact following QSR, C ON M ED Policies, standards and regulations. Works under direction from Quality Management.

• ✓*This is an on-site role in Memphis, TN.**

• ◆Supports and provides direction to product development teams for the required quality deliverables.
• ◆Ensures that product design meets customer expectations, regulatory requirements, appropriate voluntary standards, and all corporate requirements. Shows focus toward continuous improvement.
• ◆Review, assess, and approve product design documentation to ensure compliance throughout product development cycle. Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
• ◆Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
• ◆A relentless focus on the safety and the efficacy of the medical device.
• ◆Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
• ◆Review and approve design verification and design validation protocols and reports. Ensure design activities prove design inputs and user needs are adequately addressed.
• ◆Leads and provides support on risk management activities with a focus on clinician and patient safety.
• ◆Support product development through capability assessment, analyzing performance data, facilitating problem-solving activities, developing quality tools, and quality techniques.
• ◆Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
• ◆Review and approve design verification and design validation protocols and reports. Ensure design activities prove design inputs and user needs are adequately addressed.
• ◆Leads and provides support on risk management activities with a focus on clinician and patient safety.
• ◆Support product development through capability assessment, analyzing performance data, facilitating problem-solving activities, developing quality tools, and quality techniques.
• ◆Support sustaining activities such as complaint investigation and complaint trending. Monitor and analyze manufacturing and service trends. Perform Predicate Device reviews and surveillance reports. Able to perform data mining, analyze data and create trend reports.
• ◆Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
• ◆Investigates process and product issues identified through complaints and trend analysis of other conformance data. Works with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations.
• ◆Direct and facilitate investigations and the corresponding preventative actions and corrective actions that result from abnormal results, customer complaints, quality inquiries, and other quality performance indicators.
• ◆Travel

(including international): 0-5%

• ✓Support internal and external audits. Provide support for audit preparation activities. Participate in the back-room as needed.

• ✓B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 2 + years of medical device experience (or equivalent work experience), or M.S. and 1+ years of medical device experience.

• ✓Must be able to interpret and apply Quality Systems Regulations and ISO quality

and stay abreast of new industry standards and concepts.

• ✓Knowledge of design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.
• ✓Must be capable to plan schedules and to manage multiple projects simultaneously.
• ✓Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.
• ✓Design for Six Sigma training is desired along with knowledge of statistical methodologies.
• ✓Involvement in back-room support process during external audits and/or inspections.
• ✓Experience reviewing design verification and design validation protocols.
• ✓Excellent communication, problem solving, organizational, and interpersonal skills are required.
• ✓Strong technical writing skills.
• ✓Works independently with minimal direction or supervision.
• ✓Decision intelligence.

Physical

• ✓Ability to sit/stand for 8 hours.
• ✓Ability to sit at a computer terminal for an extended period.