Senior Quality Engineer

Senior Quality Engineer

On-Site position - Tucson, AZ

Essential Duties and Responsibilities

• Department Specific Duties and Responsibilities
• Support maintenance of the Quality System in accordance with 21 CFR 820, 803, 806 and ISO 13485.
• Supports preparation and maintenance of compliance to ISO 14971.
• Implement quality methods throughout the organization; drives the use of quality tools in operations and product development, assists in resolving major quality issues.
• Support activities concerned with development, application, and maintenance of Quality standards for manufacturing processes, materials, and products.

Positions Specific Dates Duties and Responsibilities

• Ensure the Quality Systems is compliant with 21 CFR 520, 803, 806 and 13485.
• Promote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques and best practices.
• Provide training and direction, as required, to junior team members within the Quality department.
• Implement cost of quality concepts, including quality cost categories, data collection, reporting etc., for manufacturing.
• Conduct inspections of components and subassemblies as required and document compliance to approved specifications and procedures.
• Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions.
• Devise sampling procedures and design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Schedule and conduct Quality system audits or material and services suppliers.
• Coordinate and oversee sterilization validation activities.
• Ensure systematic planning, and controlling of product and process quality in manufacturing:
• Processes for planning product and service development
• Material control
• Acceptance activities
• Measurement Systems
• Implement a validation program for new/changed materials, equipment, processes and components.
• Support a systematic program for quality problem solving and continuous improvement in manufacturing:
• Implement and support quality improvement models
• Corrective and preventive action
• Overcoming barriers to quality improvement
• Quality System Support
• Complaint handling and investigation
• CAPA handling and investigation
• Guidance for completion of failure investigations
• Participation in external audits - develop responses to queries during and following the audit
• Risk Management

Responsibility and Authority Affecting Quality

• Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.
• Identify and record potential problems relating to the product, process and Quality System.
• Initiate, recommend or provide solutions through designated channels.
• Record and/or report all instances of customer feedback on product.
• Verify the implementation of solutions.
• Report verbally and in writing to the Quality Manager regarding the progress and results of projects.

Position Requirements

• Skills and abilities (required for the job)
• Excellent communication skills
• Excellent writing skills
• Strong organizational skills
• Detail oriented
• Problem Solving and Critical Thinking Skills
• Ability to handle multiple tasks simultaneously
• Comfortable working independently and as a part of a cross-functional team
• Exhibits self-reliance in managing personal workload and schedule of deliverables

Education, experience and training (required for the job)

• ASQ Certified Quality Engineer and Six Sigma black belt preferred
• Bachelor's Degree in a related field and/or equivalent combination of education and experience.
• 6-10 years of experience in a regulated industry, medical device preferred
• At least 5 years' experience in a class II or III medical device company
• Note: An advanced degree in Engineering or Life Sciences accepted in lieu of professional experience.

Job Type: Full-time

Pay: $97,000.00 - $104,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• Monday to Friday

Work Location: In person