Sr Manager Quality Engineering

and quality management system processes.

• ◆Foster and sustain a culture of quality that prioritizes patient safety, product reliability, and regulatory compliance. Partner with cross-functional teams to ensure quality is embedded in all aspects of product development and manufacturing, enabling our customers to confidently care for the patients who depend on our products.
• ◆Supports and provides direction to product development teams for the required quality deliverables. Manage quality resource allocation and workload to support assigned projects.
• ◆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.
• ◆Write, review, and approve design verification and design validation protocols and reports. Ensure design activities prove design inputs and user needs are adequately addressed.
• ◆Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
• ◆Act as a mentor for employees. Be the first level resource for employees and encourage continuous improvement.
• ◆Ensure application of the risk management process throughout all 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. Able to perform data mining, analyze data and create trend reports.
• ◆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.
• ◆Support internal audits.
• ◆Provide support for audit preparation activities. Provide oversight and guidance for back-room activities.

• ✓B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 8+ years of medical device experience (or equivalent work experience)
• ✓Travel

(including international): 0-15%

• ✓Minimum of 2 years of supervisory experience.

• ✓Deep understanding of new product development, design controls, risk management, supplier management, and compliance to applicable regulatory

for medical device manufacturing.

• ✓Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.
• ✓Design for Six Sigma training is desired along with knowledge of statistical methodologies.