Sr. Quality Engineer
In this role, you will lead and facilitate the implementation of quality initiatives and continuous improvement to support the company Quality Management System. The position will lead, coach, facilitate, and support problem solving, analysis of data, and continuous improvement activities.
Drive and oversee Quality functions to support manufacturing operations. Assists in establishing systems to support the facility to drive continuous improvements and minimize the costs of non-conformance. Plans, schedules, executes, and communicates all items regarding Quality issues, events, complaints, validations, and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMPs.
location: Scottsdale, Arizona
job type: Permanent
work hours: 9 to 5
- Support the development and maintenance of the total QMS for the company to ensure compliance to standards, including ISO 13485, ISO 14971, FDA 21CFR820
- Develop risk assessment and mitigation plans through FMEA's, and other risk assessment tools.
- Oversee equipment, process, and design validations - including generation of protocols and reports, evaluation of process capability, and providing/presenting data to responsible departments.
- Liaison with company and Customers on Quality matters.
- Lead regional site Quality Engineers/ Specialists in meeting customer expectations in complaint and nonconformance investigation responses. Aid in assuring expected turn-around time metric is attained.
- Identify manufacturing and development constraints. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.
- Assists facility with Quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques
- Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC programs
- Prioritize, plan, and execute work activities in alignment with department and company priorities with minimal supervision.
- Conduct internal and external quality management system audits, publish findings, and recommendations.
- Perform all other duties as assigned
- Bachelor's degree in Engineering related field
- Minimum 5 years or experience in Quality (preferably in Medical Device)
- Experience with Customer interface and meeting customer expectations
- Experience with Project Management Tools, Quality Risk Management, and Six Sigma problem solving tools
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
- Able to comply with the company's safety policy at all times
- Able to comply with the company's quality policy at all times
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.