Quality Engineer

Performance Health is seeking a Quality Engineer to join our team in Akron, OH. In this role, you will be responsible for the coordination and administration of quality tasks including but not limited to leading internal and supplier audits, site complaint, nonconformance, CAPA & quality training activities, and supporting document change control & supplier qualification. This position is also responsible for closely partnering with operations in providing needed support & guidance to ensure compliant & effective execution of quality processes and drive product quality improvement.

Essential Job Duties & Responsibilities

• Lead nonconformance & CAPA activities to ensure compliant, timely and effective execution
• Drive timely investigation of customer complaints via identifying potential cause(s) and determining if additional investigation and Corrective Action is required via the CAPA process
• Identify and drive product quality improvement via proactive data analysis and partnering with Operations
• Guide site in the effective use of root cause investigational tools & techniques such as 5Y's, 8D, Cause/Effect, DOE, FMEA, statistical controls and Gage R&R analyses
• Support document change controls and conduct risk based assessments of changes
• Lead site Quality training activities and coordinate with subject matter experts
• Lead internal and supplier audits. Support external audits.
• Compile post market surveillance data and generate post market surveillance reports and technical documents
• Support and participate in continuous improvement and value stream/kaizen activities
• Ensure appropriate test criteria, inspection points, measurement equipment and methodology are established and documented
• Provide guidance on process verification and validation techniques such as IQ, OQ, PQ
• Assist with external regulatory body audits & inspections, and participate as subject matter as applicable
• Participate in the design and launch of new products to ensure expectations for quality, performance and regulatory compliance are understood and achieved
• Participate in selection and maintenance of suppliers through effective management of supplier audits and timely resolution of supplier defects
• Performs other duties as assigned

Job Qualifications

• Bachelor's degree in Engineering
• 1-4 years of experience working in a quality systems department with regulated industry governed by regulations such as FDA 21 CFR Parts 803, 806, & 820, ISO 14971 and ISO13485
• Proven experience using data-driven electronic quality data analysis tools such as Minitab & Excel pivot tables, and problem solving methodologies such as 6 Sigma, and SPC
• Knowledge of ISO/ EU MDR, and FDA requirements for Medical Device or OTC Drug Products strongly preferred
• Knowledge of process validation reports and test protocols for installation, operation, and performance of both software and equipment (e.g. IQ's, OQ's, PQ's), including statistical controls.
• Proven experience leading cross functional projects

Benefits

• Our benefits include healthcare; insurance benefits; retirement programs; paid time off plans; family and parenting leaves; wellness programs; discount purchase programs.
• This is a full-time position with a base salary range of $70,000 - $80,000 and the opportunity to earn bonus, plus benefits.

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.