Senior Quality Engineer Jobs

Performance Health is seeking a Sr. Quality Engineer to join our team in Akron, OH. The Sr. Quality Engineer provides support, coordination, and comprehensive product and process quality leadership throughout the organization. Promotes continuous improvement to produce the highest level of quality workmanship at a minimum cost by coordinating accurate and timely assessments of activities affecting quality and customer satisfaction.

Essential Job Duties & Responsibilities

• Provide the value stream with input in order to make timely decisions on product quality and cost reduction
• Develop specifications, determine inspection points, equipment and forms to be used, and records to be kept. Provide training and coaching of Inspection team.
• Perform other duties as assigned
• Address customer complaints to assure that root cause analysis and proper corrective action/preventive actions are taken, and results are communicated timely
• Participate with Supply Chain to select suppliers, manage the audit and qualification of new suppliers
• Analyze non-conformances to determine root cause and monitor corrective actions for effectiveness
• Assist Quality Sr. Management in developing & maintaining the QMS procedures & work instructions in compliance with ISO 9001, ISO 13485, 21 CFR 201and 211, 21 CFR 820 and other regulatory quality standards
• Perform failure analysis and ensure that timely corrective/preventive action is taken
• Use appropriate quality tools (such as 6 Sigma methodologies, DOE, FMEA, and Gage R&R analyses) to solve problems identified during quality assurance activities
• Develop and implement methods and procedures for disposition of nonconforming material; define methods to assess cost of nonconformities
• Establish and implement effective process controls and product test requirements
• Manage process verification and validation activities according to FDA and all other global regulatory agency requirements
• Identify areas of improvement within the organization and drive to completion by establishing partnerships with applicable departments
• Participate in the design process and new product launches to ensure that expectations for quality, performance, regulatory compliance, and delivery are met

Job Qualifications

• 6+ years of experience working within the medical drug/device regulated industry (e.g. FDA, ISO)
• Demonstrated advance team leadership skills and ability to work and make decisions independently and lead others to the completion of assigned tasks
• Bachelors of Science degree in Engineering or other related technical field
• In depth knowledge and working application of validation principles and guidelines and industry practice
• Demonstrated understanding of metrology, calibration, and inspection techniques
• Demonstrated understanding of data-driven Quality tools such as SPC, CPK, Gage R & R, and problem solving methodologies (e.g. 8D, 6 Sigma, 5-Why), and ability to teach the use of such tools to a wide range of associates
• Ability to travel up to 10% of the time, including overnight travel
• Proficiency in Word, Excel, PowerPoint, Minitab, Access and databases
• In depth knowledge and working application of PFMEA and Risk Analysis
• Demonstrated ability to effectively manage multifaceted projects and to resolve complex quality-related issues

To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Performance Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender, gender identity, sexual orientation, race, color, religion, national origin, disability status, protected Veteran status, age, genetic information, and any other characteristic protected by law.