Primary Function: The Quality Engineer is responsible for supporting customers (internal & external) in matters related to product quality, as directed by the Quality Manager.
Areas of responsibility include reactively correcting problems that create quality complaints, responding to customers, and implementing quality system improvements to protect customers.
Primary Duties:
• Lead and/or participate in process and product problem-solving activities including risk management documents and risk control.
• Participate on cross-functional new product development teams with focus on the execution of quality plans.
• Develop and implement statistically valid sampling plans, designed experiments, may require capability studies, SPC and trend analysis.
• Constantly review the current quality system and recommend / implement improvements as needed.
• Review collected data to perform statistical analysis and recommend process / product changes to improve quality.
• Lead projects focused on quality system, and product quality improvements.
• Report on the performance of the quality system.
• Participate in strategic planning and audits of internal and supplier quality systems.
• Participate/support external and internal quality system audits.
• Instruct other employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborate with other departments and facilities within the company on quality related issues.
• Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
• Additional duties as assigned
Direct Reports: none.
Musts (minimum criteria):
• Minimum of 2 years in a similar manufacturing quality role
• Exposure to ISO 9001, IATF 16949, or other comparable quality system.
• Experience and comfort utilizing Microsoft office tools, accessing customer websites/inputting data.
• Understands basic quality statistics (averages, standard deviations, ranges, capability indices, etc.)
Abilities
• Excellent problem-solving skills
• Experience working on cross-functional teams and on own initiative
• Demonstrated excellent organizational, oral and written communications skills
• Commitment to learn new skills and tools as they become relevant
• Flexibility and ability to self-start on new tasks, problem-solving with minimal supervision and to work in a diverse work environment dealing with multiple tasks with deadlines
Desired
• Experience in both design and manufacturing environments
• Experience in medical device industry, preferably with electromechanical devices and medical device software
• ASQ Certified Quality Engineer or other ASQ Certification
• AIAG Core Tools experience (FMEA, PPAP, Control Plans, MSA, SPC)
• Technical writing skills, experience creating SOPs in a Quality Management System
WORKING CONDITIONS
Work is performed in a rubber manufacturing facility and standard office environment. Essential functions require sufficient physical ability and mobility to work in an office setting; to stand or sit for prolonged periods of time; to occasionally bend, kneel and reach; to lift, carry, push/pull light to moderate amounts of weight; to operate office equipment that may require fine motor coordination (i.e., use of a keyboard). Reasonable accommodations may be made when an employee has a qualified disability but can still perform the essential functions of the job (without creating an undue hardship).
