Sr. Quality Engineer

Sr. Quality Engineer at Erbe Medical, LLC Sr. Quality Engineer at Erbe Medical, LLC in Tempe, Arizona Posted in 2 days ago.

Type:

Full-Time Job Description:

Essential Responsibilities This position is responsible for contributing to the development, implementation, and execution of the full product lifecycle quality management program at Erbe, including quality planning and execution for manufacturing readiness and production transfer. As a full-lifecycle quality engineer, your job duties include creation and collaboration on design and process risk management, measurement systems analysis, design verification and validation, supplier qualification, process validation, non-conformance and CAPA, post-market surveillance, and cross-functional transfer of products and processes into production. This position is also responsible for executing to both departmental and organizational goals. Interfaces with vendors (including Erbe GmbH) and in-house personnel on development of products. Develops, revises, and/or reviews product specifications regarding contract-manufactured products (including packaging, labeling, sterilizing, biological testing, etc.) involved with Erbe USA. Develops, revises, and/or reviews product and process risk management files. Leads or supports supplier qualification, outsourced process validation, and ongoing supplier controls/performance reviews. Leads or supports occasional supplier audits. Develops, revises, and/or reviews measurement systems analysis. Leads or supports manufacturing production transfer activities, ensuring process readiness, regulatory compliance, and quality integration across Engineering, Manufacturing, Supplier Quality, and materials management. Authors, reviews, and/or approves validation documents and records, including IQ, OQ, and PQ protocols/reports, to support manufacturing readiness and transfer to production. Develops and maintains process documentation to ensure manufacturing methods, inspection requirements, and procedures are clearly defined, controlled, and deployable for production. Provides technical quality support for manufacturing processes, including evaluation of process changes to improve product quality, yield, throughput, and overall equipment/process efficiency. Collaborates on test method development and reviews testing methodologies, equipment, and documentation to confirm conformance to established standards and specifications. Works with drawings, specifications, and manufacturing records to ensure complete and accurate transfer of product requirements into production. Applies statistical methods and FMEA-based risk tools to support process capability, validation effectiveness, and quality decision-making during product and process transfer. Leads or supports post-market surveillance activities. Supports the development of regulatory submissions. Troubleshoots product non-conformances/failures to determine root causes and provides recommendations for corrective/preventive measures (Includes identifying, documenting, and recommending solutions to the quality problem.). Identifies preventive actions to minimize/eliminate potential non-conformances or problems. Verifies implementation and effectiveness of solutions to quality related issues. Creates, revises, and implements quality procedures and process documentation (i.e., inspection/testing documentation, work instructions, SOPs, and related records). Performs and documents training. Additional duties as assigned by Manager. Supervisory Responsibility This position is an individual contributor and has no direct supervisory responsibility. Work Environment This position operates in a professional office and manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The position also interacts with manufacturing equipment, production processes, and finished devices on the manufacturing floor as needed to support validation, transfer, and issue resolution. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms. Position Type and Expected Hours of Work This is a full-time position. Days and hours of work are Monday through Friday, 7:30 a.m. to 4:00 p.m. Occasional evening and weekend work may be required as job duties demand. Travel This position may require occasional travel, with limited international travel included. Required Education and Experience Bachelor's degree in engineering, biology, biomedical technology, chemistry, or electronics. 5+ years' experience in quality engineering with medical devices; strong preference for experience supporting manufacturing process transfer, process validation, and class II+ disposable accessories. Experience authoring and/or reviewing validation deliverables (including IQ, OQ, and PQ), test methods, and process documentation to support production transfer preferred. Working knowledge of

FDA/QMSR, ISO 13485, ISO

14971, and applicable EU requirements preferred. ASQ Certified Quality Engineer preferred. Position Requirements Thorough understanding of full lifecycle quality engineering skillset, including design control, risk management, process validation, supplier quality, and manufacturing transfer. Demonstrated ability to lead or support cross-functional product and process transfer activities with Engineering, Manufacturing, materials management, and suppliers. Strong working knowledge of drawings, specifications, manufacturing records, test methods, and statistical/risk tools (e.g., MSA, FMEA, and process capability) to support quality decisions. Excellent verbal and written communications required; strong facilitation and interpersonal skills required. Must be able to communicate complex information to all levels within the organization. Demonstrated high quality computer skills including MS Office (particularly Excel), Outlook and some exposure to electronic quality systems. Must be highly detail-oriented and produce high quality work in a high- volume environment. Must be able to work independently using experience and judgment to make sound decisions. Competencies Problem Solving/Analysis. Results Driven. Detail Orientation. Customer Focus. Technical Capacity. Communication Proficiency. Additional Eligibility Qualifications None required for this position. Work Authorization/Security Clearance Employees must be legally authorized to work in the United States. Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government. AAP/EEO Statement Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non-merit-based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. At-Will Employment This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employment-at-will rights at any time. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the notice from the Department of Labor. See job description