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Sr Quality Engieer- Medical Device- Agawam, Ma
2 months ago
The client is a prominent provider of complex sheet metal and machined production parts, assemblies, and weldments across various industries, including electrical transmission, warehouse automation, aerospace & defense, medical, food, and industrials. With multiple locations spanning several states in the U.S. and Monterrey, Mexico, they offer extensive in-house manufacturing capabilities such as laser cutting, sheet metal fabrication, CNC machining, robotic welding, stamping, and tool and die manufacturing. They specialize in mid- to high-volume production with lights-out manufacturing capabilities, emphasizing quality and efficiency in their operations.
Job Description
Design, document, and implement process control methods, including Statistical Process Control (SPC), for testing and inspection.Conduct root cause analysis using appropriate tools to identify and implement robust solutions.Manage large projects to ensure timelines are met and resources are effectively communicated and directed.Conduct internal audits of the quality system.Lead and facilitate Corrective and Preventive Action (CAPA) meetings, ensuring timely resolution of actions.Guide advanced product quality planning (APQP) processes to validate products and processes.Develop and maintain tools for reporting Quality System metrics accurately.Utilize past performance data and tools like DOE, DFM, FMEAs, GD&T, and process capability to work with engineering on process improvement.Assist in material disposition by conducting failure analysis and recommending corrective actions as part of the Material Review Board (MRB).Lead training initiatives, including New Employee Orientation and Blueprint Reading, collaborating with Human Resources for additional quality training.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
Preferably 3-5 years of recent, relevant experience in a manufacturing environment.Thorough understanding of manufacturing processes and tooling.Experience in Medical Systems and audits, particularly with ISO 13485, is desirable.Strong knowledge of ISO 9001 Quality Systems and audit criteria.Previous experience conducting audits is advantageous.What's on OfferCompetitive compensation package commensurate with experience and qualifications.Comprehensive benefits package including health insurance and retirement plans.Opportunity to work with advanced manufacturing technologies and processes.Potential for career growth and professional development within a dynamic organization.Collaborative work environment that emphasizes teamwork and innovation.Commitment to equal employment opportunities and a supportive workplace culture.
